Pholcodine Linctus
*-
68MM
168MM
CARRIER:
•*
130.5MM
8MM6.5MM
Pholcodine Linctus B.P.
Do not give to children under 6 years.
ru
Please read and keep the attached leaflet for full instructions.
Uses: For relief of dry, tickly coughs.
IK Do not take:
If you have liver or kidney failure
If you have difficulty breathing
If you have long-term lung problems
or an infection which produces lots of
phlegm on the chest
If you are taking monoamine oxidase
inhibitors (for depression), or have taken
them in the last 14 days
If you are taking other cough and cold
medicines
If you are pregnant or breastfeeding,
unless your doctor tells you to
A.
f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)
• If you have a cough which produces lots of phlegm
f Talk to your pharmacist or doctor
• If you have other liver or kidney problems
This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take
Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.
Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.
| Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless their doctor tells you to.
If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away, talk to your doctor.
Do not store above 25°C.
Keep all medicines out of the sight an<{ reach of children.
Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.
Also contains: sucrose.
If you need more advice ask your pharmacist, PL 00014/5718R [P]
Use by the date on the label edge.
The Boots Company PLC Nottingham NG2 3AA 200 ml 0
_________________62-42.-138
u
CL
-1.5MM
TECH1M1CAL INFO: PRINTER PLEASE NOTE
Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.
60MM
15MM
4MM
141MM
12MM
148MM
6 PAGE LEAFLET
Trident Reference No: BTC222547 | |
Zen Ref: |
TR1102040 |
Category: |
Healthcare |
Sub-Category: |
Cough Cold |
Brand: |
Good |
Pack Type: |
Label/Leaflet |
Variant: |
Pholcodine Linctus BP 200ml |
Action: |
B |
Date: |
12/05/16 |
Country: |
UK |
Component Code: |
PCNK2 |
Item Code: |
62-42-138 |
CAD Ref No: |
168 x 68mm |
Printer: |
N/A |
Substrate: |
White Plastic |
Barcode Type: |
EAN 13 |
Barcode Number: |
5045096242137 |
Magnification: |
80% |
Barcode Truncated By: 7.3 mm | |
(smallest bar] | |
Edgemark Position: |
N/A |
Pharmacode No/NE: |
N/A |
Technical ft Non Printing Items Cutter Guides
Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.
136mm
133mm
133mm
PANTONE 280 C |
PANTONE 2736 C |
Overall Water Varnish |
Braille | ||||
= |
= |
_3_ |
_4_ |
2.5mm ■
68mm
2.5mm ■
68mm
■ Please read and keep the attached
X Do not take:
If you have liver or kidney failure
{♦If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest
• If you are taking other cough and cold medicines, or monoamine oxidase inhibitors (for depression)
• If you are pregnant or breastfeeding, unless your doctor tells you to
f Talk to your doctor:
• If you have a long-term cough or asthma
• If you have a cough which produces lots of phlegm
f Talk to your pharmacist or doctor:
• If you have other liver or kidney problems This medicine can make you feel sleepy.
Do not drive or operate machines until you are sure you are not affected.
/How to take
Check the seal is not broken before first use. Jf lie, dQjioUake.themedicine. _ _
leaflet for full instructions.
Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.
Do not give to children under 6 years._
I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.
If a child's symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away, talk to your doctor.
Keep all medicines out of the sight and reach of children.
Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.
Also contains: sucrose. „
PL 00014/5718R 0
Use by the date on the label edge.
The Boots Company PLC Nottingham NG2 3AA
Pholcodine
Linctus B.P.
_ 6242-138 .
Relieves dry, tickly coughs
200 ml e
141mm
4mm
Pholcodine Linctus B.P.
Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice
^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.
For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"
is provided at the end of this leaflet.
pefore you take this medicine
This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
_P_CNKH___________________________
XDo not take:
• If you are allergic to any of the ingredients
• If you have liver or kidney failure
• If you have difficulty breathing
• If you have long-term lung problems or an infection which produces lots of phlegm on the chest
• If you are taking monoamine oxidase inhibitors
(for depression), or have taken them in the last 14 days
• If you are taking any other cough and cold medicines
• If you have an intolerance to some sugars,
unless your doctor tells you to (this medicine contains sucrose)
•If you are pregnant or breastfeeding, unless your doctor tells you to
|f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)
If you have a cough which produces lots of phlegm
if Talk to your pharmacist or doctor:
]• If you have other liver or kidney problems (see “Do not take”)
If you take other medicines:
- Water tablets (diuretics), medicines to treat high blood pressure
- Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy
- Medicines for depression or other mental health conditions
(Other important information
If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink a!p°h_o[(e.g. wjne,_beer,spirits) whitettaWn^Jhjs medicine.
This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.
■ Do not drive or use machines while taking this medicine until you are sure you are not affected
• It is an offence to drive if this medicine affects your ability to drive
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.
2.5mm
60mm
Es
TRIDENT
Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AF, England. T: +44 (0) 1482 828100
Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.
FACE PAGE 1
138mm
PAGE 2
138mm
PAGE 3
STUDIO USE ONLY Michael Woodhead vl.O
Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20
•+
133mm
-*
133mm
-*■
136mm
/How to take this medicine
Check the seal is not broken before first use. If it is, do not take the medicine.
Age |
How much |
How often |
Adults and children of 12 years and over |
Two 5 ml SDOonfuls |
3 or 4 times a day, if you needto |
Children of 6 to 11 years |
One 5 ml spoonful |
3 or 4 times a day, if you needto |
Swallow this medicine.
Do not give to children under 6 years.
Do not take more than the amount recommended above.
Do not give to a child for more than 5 days, unless their doctor tells you to.
If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away talk to your doctor.
? If you take too much: Talk to a doctor straight away.
Possible side effects
Most people will not have problems, but some may get some.
f If you get any of these serious side effects, stop taking the medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects see your pharmacist or doctor:
• Other allergic reactions such as skin rash
• Feeling sick, being sick, constipation
• Feeling drowsy, dizzy, excited or confused
• Phlegm on the chest Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label. You can also report side effects directly via the Yellow Card scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on _ _the_s_afety_of thjs_meajqhe^ _
Do not store above 25°C.
Keep this medicine in a safe place out of the sight and reach of children.
Use by the date on the label edge.
What is in this medicine
Each 5 ml of oral solution contains Pholcodine 5 mg. Also contains: sucrose, purified water, citric acid, glycerol (E422), sodium benzoate, domiphen bromide.
This bottle contains a colourless to pale yellow solution. A gradual yellowing of the solution on storage is a characteristic of this product.
Who makes this medicine Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA
Treating coughs and colds in children
It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.
Follow these simple steps, which may help your child overcome their cough or cold:
1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).
Your pharmacist will be able to help you find a suitable product if in doubt.
[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.
£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.
Base/Pages 2-6 | |
Main Headings: |
lOpt |
Sub Headings: |
9pt |
Body Copy: |
8pt |
Page 1 | |
Main Headings: |
9.5pt |
Sub Headings: |
8.5pt |
Body Copy: |
7.5pt |
Product Name:
Pholcodine Linctus BP
2.5mm
60mm
Product Licence No.: PL00014/5718R Wording Ref: Type IA 'do and tell'vl 27/1/2015 (BTCl 73887 B)
Status: Type IA ‘do and tell'
Pack Details: Amber coloured glass bottle fitted with a roll-on
piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.
Pack Size: 200 m|
Version No. Date Issued
Reason For Change
27/1/2015
01/04/2016
11/05/2016
Reformulation, removal of driver warning flash, addition of yellow card statement
Addition of colour statement and update to PL number following RFI
Additional wording added to the description of the product following email correspondence from the MHRA
138mm
PAGE 4
4mm
138mm
PAGE5
->~4-
141mm
PAGE6
•*
130.5MM
8MM6.5MM
Pholcodine Linctus B.P.
Do not give to children under 6 years.
ru
Please read and keep the attached leaflet for full instructions.
Uses: For relief of dry, tickly coughs.
IK Do not take:
If you have liver or kidney failure
If you have difficulty breathing
If you have long-term lung problems
or an infection which produces lots of
phlegm on the chest
If you are taking monoamine oxidase
inhibitors (for depression), or have taken
them in the last 14 days
If you are taking other cough and cold
medicines
If you are pregnant or breastfeeding,
unless your doctor tells you to
A.
f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)
• If you have a cough which produces lots of phlegm
f Talk to your pharmacist or doctor
• If you have other liver or kidney problems
This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take
Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.
Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.
| Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless their doctor tells you to.
If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away, talk to your doctor.
Do not store above 25°C.
Keep all medicines out of the sight an<{ reach of children.
Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.
Also contains: sucrose.
If you need more advice ask your pharmacist, PL 00014/5718R [P]
Use by the date on the label edge.
The Boots Company PLC Nottingham NG2 3AA 200 ml 0
_________________62-42.-138
u
CL
-1.5MM
TECH1M1CAL INFO: PRINTER PLEASE NOTE
Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.
60MM
• |
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• |
• |
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• |
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• |
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• |
• |
• • |
• • |
• |
• |
• |
• |
• • | ||
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• |
• |
• • |
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• |
• • |
• |
• • | ||
• |
• |
• |
• • |
• |
• |
• |
• |
15MM
4MM
141MM
12MM
Boots
Pholcodine
148MM
Linctus B.P.
6 PAGE LEAFLET
Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.
136mm
133mm
133mm
Trident Reference No: BTC222547 | |
Zen Ref: |
TR1102040 |
Category: |
Healthcare |
Sub-Category: |
Cough Cold |
Brand: |
Good |
Pack Type: |
Label/Leaflet |
Variant: |
Pholcodine Linctus BP 200ml |
Action: |
B |
Date: |
12/05/16 |
Country: |
UK |
Component Code: |
PCNK2 |
Item Code: |
62-42-138 |
CAD Ref No: |
168 x 68mm |
Printer: |
N/A |
Substrate: |
White Plastic |
Barcode Type: |
EAN 13 |
Barcode Number: |
5045096242137 |
Magnification: |
80% |
Barcode Truncated By: 7.3 mm | |
(smallest bar] | |
Edgemark Position: |
N/A |
Pharmacode No/NE: |
N/A |
Technical ft Non Printing Items Cutter | Guides
Colours
PANTONE 280 C |
PANTONE 2736 C |
Overall Water Varnish |
Braille | ||||
= |
= |
_3_ |
_4_ |
2.5mm ■
68mm
2.5mm ■
68mm
■ Please read and keep the attached X Do not take:
If you have liver or kidney failure {♦If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest
• IfJ ju an. takin„ other cc gh ar,
coil medicir. s, or *)n®i#ne»xidase inhibitors ftor dep sssior) •
• If you are pregnant or breastfeeding,
urAsayos doct» tells fDu to • • • •
• If have a longterm Ibugh or asthBa
• If you have a cough which produces lots of
f Ta.< to fbur pharmacist oi doctor:
• IfyouhaveothemerorkidneiTSrobldB* • This medicine can make you feel sleepy.
Do not drive or operate machines until you are sure you are not affected.
/How to take
Check the seal is not broken before first use. Jf it is, dQjioUake.themedicine.___
leaflet for full instructions.
Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.
Do not give to children under 6 years._
I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.
"a chi|d's ^mptoms worsen at any time,
Ik to a pllrmacEur doctor _
symptong ao not go away, talk to your doctor.
Keep all ngedicines or r* the sight and reacted ch 'd in • •
Active ingredient: Cadt5 ml of Aral
solution contains Pholcodine 5 mg.
Also contains: sucrose. „
PL 00014/5718R 0 Use by the date on the label edge.
The Boots Company PLC Nottingham NG2 3AA
Pholcodine
Linctus B.P.
Pholcodine Linctus B.P.
Read all of this leaflet carefully because it contains important information for you.
_ 6242-138 .
Relieves dry, tickly coughs
200 ml e
|» Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice
^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.
For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"
is provided at the end of this leaflet.
pefore you take this medicine
This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
_P_CNKH___________________________
XDo not take:
• If you are allergic to any of the ingredients
• If you have liver or kidney failure
• If you have difficulty breathing
• If you have long-term lung problems or an infection which produces lots of phlegm on the chest
• If you are taking monoamine oxidase inhibitors
(for depression), or have taken them in the last 14 days
• If you are taking any other cough and cold medicines
• If you have an intolerance to some sugars,
unless your doctor tells you to (this medicine contains sucrose)
•If you are pregnant or breastfeeding, unless your doctor tells you to
|f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)
If you have a cough which produces lots of phlegm
if Talk to your pharmacist or doctor:
]• If you have other liver or kidney problems (see “Do not take”)
If you take other medicines:
- Water tablets (diuretics), medicines to treat high blood pressure
- Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy
- Medicines for depression or other mental health conditions
(Other important information
If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink a!p°h_o[(e.g. wjne,_beer,spirits) whitettaWn^Jhjs medicine.
This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.
■ Do not drive or use machines while taking this medicine until you are sure you are not affected
• It is an offence to drive if this medicine affects your ability to drive
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.
2.5mm
60mm
E3
TRIDENT
Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, Hll7 3AF, England. T: +44 (0) 1482 828100
Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.
141mm
4mm
FACE PAGE 1
138mm
PAGE 2
138mm
PAGE 3
STUDIO USE ONLY Michael Woodhead v1.0
Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20
•*
133mm
-*
133mm
-A
136mm
/How to take this medicine
Check the seal is not broken before first use. If it is, do not take the medicine.
Age |
How much |
How often |
Adults and children of 12vearsandover |
Two 5 ml spoonfuls |
3 or 4 times a day, if you needto |
Children of 6 to 11 years |
One 5 ml spoonful |
3 or 4 times a day, if you needto |
Swallow this medicine.
Do not give to children under 6 years.
Do not take more than the amount recommended above.
Do not give to a child for more than 5 days, unless their doctor tells you to.
If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away talk to your doctor.
? If you take too much: Talk to a doctor straight away.
Possible side effects
Most people will not have problems, but some may get some.
f If you get any of these serious side effects, stop taking the medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects see your pharmacist or doctor:
• Other allergic reactions such as skin rash
• Feeling sick, being sick, constipation
• Feeling drowsy, dizzy, excited or confused
• Phlegm on the chest Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label. You can also report side effects directly via the Yellow Card scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on _ _the_s_afety_of thjs_meajqhe^ _
Do not store above 25°C.
Keep this medicine in a safe place out of the sight and reach of children.
Use by the date on the label edge.
What is in this medicine
Each 5 ml of oral solution contains Pholcodine 5 mg. Also contains: sucrose, purified water, citric acid, glycerol (E422), sodium benzoate, domiphen bromide.
This bottle contains a colourless to pale yellow solution. A gradual yellowing of the solution on storage is a characteristic of this product.
Who makes this medicine Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA
Treating coughs and colds in children
It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.
Follow these simple steps, which may help your child overcome their cough or cold:
1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).
Your pharmacist will be able to help you find a suitable product if in doubt.
[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.
£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.
Base/Pages 2-6 | |
Main Headings: |
lOpt |
Sub Headings: |
9pt |
Body Copy: |
8pt |
Page 1 | |
Main Headings: |
9.5pt |
Sub Headings: |
8.5pt |
Body Copy: |
7.5pt |
2.5mm
60mm
Product Name: Pholcodine Linctus BP
Product Licence No.: PL00014/5718R
Wording Ref: Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)
138mm
PAGE 4
4mm
138mm
PAGE5
->~4-
141mm
PAGE6
Type IA 'do and tell'
Amber coloured glass bottle fitted with a roll-on pilfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.
200 ml
Status:
Pack Details:
Pack Size:
Version No. |
Date Issued |
Reason For Change |
1 |
27/1/2015 |
Reformulation, removal of driver warning flash, addition of yellow card statement |
2 |
01/04/2016 |
Addition of colour statement and update to PL number following RFI |
3 |
11/05/2016 |
Additional wording added to the description of the product following email correspondence from the MHRA |
•*
130.5MM
8MM6.5MM
1.5MM
TECHNICAL INFO: PRINTER PLEASE NOTE
Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.
• |
• |
• |
• |
• | |||||
• |
• |
• |
• • |
• | |||||
• |
• |
• |
• | ||||||
• |
• • |
• |
• |
• |
• • |
• • | |||
• |
• |
• |
• |
• | |||||
• |
• |
• • |
• • |
• |
• |
• |
• |
• • | |
• |
• |
• |
• • |
• |
• • • |
• |
• • | ||
• |
• |
• |
• • |
• |
• |
• |
• |
◄-►
148MM
Trident Reference No: BTC222547 | |
Zen Ref: |
TR1102040 |
Category: |
Healthcare |
Sub-Category: |
Cough Cold |
Brand: |
Good |
Pack Type: |
Label/Leaflet |
Variant: |
Pholcodine Linctus BP 200ml |
Action: |
B |
Date: |
12/05/16 |
Country: |
UK |
Component Code: |
PCNK2 |
Item Code: |
62-42-138 |
CAD Ref No: |
168 x 68mm |
Printer: |
N/A |
Substrate: |
White Plastic |
Barcode Type: |
EAN 13 |
Barcode Number: |
5045096242137 |
Magnification: |
80% |
Barcode Truncated By: 7.3 mm | |
(smallest bar] | |
Edgemark Position: |
N/A |
Pharmacode No/NE: |
N/A |
Technical Et Non Printing Items Cutter Guides
136mm
133mm
133mm
PANTONE 280 C |
PANTONE 2736 C |
Overall Water Varnish |
Braille | ||||
= |
= |
_3_ |
_4_ |
4mm
FACE PAGE 1
PAGE 2
PAGE 3
Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, HU7 3AP, England. T: +44 (0) 1482 828100
Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.
STUDIO USE ONLY Michael Woodhead v1.0
Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20
•+
-*■
Base/Pages 2-6 | |
Main Headings: |
lOpt |
Sub Headings: |
9pt |
Body Copy: |
8pt |
Page 1 | |
Main Headings: |
9.5pt |
Sub Headings: |
8.5pt |
Body Copy: |
7.5pt |
Product Name:
Pholcodine Linctus BP
Product Licence No.: PL00014/5718R Wording Ref: Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)
Status: Type IA 'do and tell'
Pack Details: Amber coloured glass bottle fitted with a roll-on
piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.
Pack Size: 200 m|
Version No. Date Issued
Reason For Change
27/1/2015
01/04/2016
11/05/2016
Reformulation, removal of driver warning flash, addition of yellow card statement
Addition of colour statement and update to PL number following RFI
Additional wording added to the description of the product following email correspondence from the MHRA
2.5mm
68mm
Pholcodine Linctus B.P.
1 Please read and keep the attached ! leaflet for full instructions.
1 Uses: For relief of dry, tickly coughs.
XDo not take:
| • If you have liver or kidney failure i • If you have difficulty breathing 1 • If you have long-term lung problems | or an infection which produces lots of i phlegm on the chest 1 • If you are taking monoamine oxidase ! inhibitors (for depression), or have taken i them in the last 14 days | • If you are taking other cough and cold i medicines
1 • If you are pregnant or breastfeeding,
| unless your doctor tells you to
f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)
• If you have a cough which produces lots of phlegm
f Talk to your pharmacist or doctor
• If you have other liver or kidney problems
This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take
Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.
Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.
Do not givelo children under 6 years. 1 | Warning: Do not exceed the stated dose
Do not give to a child for more than 5 i days, unless their doctor tells you to. 1 If a child’s symptoms worsen at any time, | talk to a pharmacist or doctor.
If symptoms do not go away, talk to your ] doctor. i
Do not store above 25°C.
Keep all medicines out of the sight an<{ reach of children. i
Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.
Also contains: sucrose.
If you need more advice ask your pharmacist. | PL 00014/5718R [P]
Use by the date on the label edge. |
The Boots Company PLC Nottingham '
NG2 3AA 200 mid
62-42.-138
6 PAGE LEAFLET
Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.
■ Please read and keep the attached X Do not take:
• If you have liver or kidney failure
• If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest
• If you are taking other cough and cold medicines, or monoamine oxidase inhibitors (for depression)
• If you are pregnant or breastfeeding, unless your doctor tells you to
f Talk to your doctor:
• If you have a long-term cough or asthma
• If you have a cough which produces lots of phlegm
f Talk to your pharmacist or doctor:
• If you have other liver or kidney problems This medicine can make you feel sleepy.
Do not drive or operate machines until you are sure you are not affected.
/How to take
Check the seal is not broken before first use. If lie, dQjiQUake.tlKmedi.cine. _ _
leaflet for full instructions.
Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.
Do not give to children under 6 years._
I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.
If a child's symptoms worsen at any time, talk to a pharmacist or doctor.
Pholcodine
Linctus B.P.
If symptoms do not go away, talk to your o doctor.
Keep all medicines out of the sight ° and reach of children. ^
Active ingredient: Each 5 ml of oral ro solution contains Pholcodine 5 mg. -e-
Also contains: sucrose. „
Use by the date on the label edge. ^
The Boots Company PLC Nottingham v N(32_3AA_________________62-42-138
Relieves dry, tickly coughs
200 ml e
Pholcodine Linctus B.P.
Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice
^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.
For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"
is provided at the end of this leaflet.
pefore you take this medicine
This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
_P_CNKH___________________________
XDo not take:
• If you are allergic to any of the ingredients
• If you have liver or kidney failure
• If you have difficulty breathing
• If you have long-term lung problems or an infection which produces lots of phlegm on the chest
• If you are taking monoamine oxidase inhibitors
(for depression), or have taken them in the last 14 days
• If you are taking any other cough and cold medicines
• If you have an intolerance to some sugars,
unless your doctor tells you to (this medicine contains sucrose)
•If you are pregnant or breastfeeding, unless your doctor tells you to
|f Talk to your doctor:
• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)
If you have a cough which produces lots of phlegm
if Talk to your pharmacist or doctor:
]• If you have other liver or kidney problems (see “Do not take”)
If you take other medicines:
- Water tablets (diuretics), medicines to treat high blood pressure
- Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy
- Medicines for depression or other mental health conditions
(Other important information
If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink afeohoKe.g.^ne.b^r.spintsJwhitettaWn^Jhjs medicine.
This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.
■ Do not drive or use machines while taking this medicine until you are sure you are not affected
• It is an offence to drive if this medicine affects your ability to drive
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.
FACE PAGE 1 |
PAGE 2 |
PAGE 3 |
133mm |
133mm |
136mm |
/’How to take this medicine
i Check the seal is not broken before first use. If it is, 1 do not take the medicine.
Age |
How much |
How often |
Adults and children of 12 years and over |
Two 5 ml SDOonfuls |
3 or 4 times a day, if you needto |
Children of 6 to 11 years |
One 5 ml spoonful |
3 or 4 times a day, if you needto |
Swallow this medicine.
Do not give to children under 6 years.
Do not take more than the amount recommended above.
Do not give to a child for more than 5 days, unless their doctor tells you to.
If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.
If symptoms do not go away talk to your doctor.
? If you take too much: Talk to a doctor straight away.
Possible side effects
Most people will not have problems, but some may , get some. '
? If you get any of these serious side effects, ! stop taking the medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck,
tongue or throat (severe allergic reactions) ,
If you get any of the following side effects see | your pharmacist or doctor:
• Other allergic reactions such as skin rash
• Feeling sick, being sick, constipation
• Feeling drowsy, dizzy, excited or confused
• Phlegm on the chest Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side, effects not listed on this label. You can also report ' side effects directly via the Yellow Card scheme at: ] www.mhra.aov.uk/vellowcard. By reporting side i effects you can help provide more information on 1 Jhe_s_afety_of thjs_meajcine^ _
] Do not store above 25°C. i Keep this medicine in a safe place out of the sight 1 and reach of children, i Use by the date on the label edge.
What is in this medicine
] Each 5 ml of oral solution contains Pholcodine 5 mg. i Also contains: sucrose, purified water, citric acid,
| glycerol (E422), sodium benzoate, domiphen I bromide.
] This bottle contains a colourless to pale yellow i solution. A gradual yellowing of the solution on ] storage is a characteristic of this product.
Who makes this medicine ! Manufactured by the Marketing Authorisation holder i The Boots Company PLC Nottingham NG2 3AA ] Leaflet prepared April 2016 i If you would like any further information about this ' medicine, please contact The Boots Company PLC I Nottingham NG2 3AA
Treating coughs and colds in children
It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.
Follow these simple steps, which may help your child overcome their cough or cold:
1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).
Your pharmacist will be able to help you find a suitable product if in doubt.
[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.
£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with [blocked noses who are having trouble feeding.
2.5mm
60mm
TECH1M1CAL INFO: PRINTER PLEASE NOTE
Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.
ARTWORK ONLY
Category: |
Healthcare |
Sub-Category: |
Cough Cold |
Brand: |
Good |
Pack Type: |
Label/Leaflet |
Variant: |
Pholcodine Linctus BP 200ml |
Action: |
B |
Date: |
12/05/16 |
Country: |
UK |
Component Code: |
PCNK2 |
Item Code: |
62-42-138 |
CAD Ref No: |
168 x 68mm |
Printer: | |
Substrate: |
White Plastic |
Barcode Type: |
EAN 13 |
Barcode Number: |
5045096242137 |
Magnification: |
80% |
Barcode Truncated By: 7.3 mm | |
(smallest bar] | |
Edgemark Position: |
N/A |
Pharmacode No/NE: |
N/A |
Technical ft Non Printing Items Cutter Guides
PAMONE280 C |
PANTONE 2736 C |
Overall Water Varnish |
Braille | ||||
= |
= |
_3_ |
_4_ |
STUDIO USE ONLY
ARTWORK TEXT SIZE
Base/Pages 2-6 | |
Main Headings: |
lOpt |
Sub Headings: |
9pt |
Body Copy: |
8pt |
Page 1 | |
Main Headings: |
9.5pt |
Sub Headings: |
8.5pt |
Body Copy: |
7.5pt |
Product Name:
Pholcodine Linctus BP
PACK MOCK UP
Product Licence No.: PL00014/5718R Wording Ref: Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)
Status: Type IA 'do and tell'
Pack Details: Amber coloured glass bottle fitted with a roll-on
piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.
Pack Size: 200 m|
Version No. Date Issued
Reason For Change
27/1/2015
01/04/2016
11/05/2016
Reformulation, removal of driver warning flash, addition of yellow card statement
Addition of colour statement and update to PL number following RFI
Additional wording added to the description of the product following email correspondence from the MHRA
138mm
PAGE 4
4mm
138mm
PAGE5
141mm
PAGE6
Hinge is formed on right hand side of leaflet.
This is unconventional for left to right reading.