PANADOL- acetaminophen suspension 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 5mL)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
colds
flu
headache
toothache
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose can cause serious health problems. In case of oversdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions:

This product does not contain directions or complete warnings for adult use

do not take more than directed (see overdose warning)
find right dose in chart. If possible use weight to dose; otherwise, use age
if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor
do not take more than 5 doses in 24 hours, unless directed by a doctor
use only with enclosed pre-marked measuring cup for accuracy. Do not use any other dosing device.

Age

Weight

Dosage

under 2 yrs

under 24 lbs

ask a doctor

2 - 3 yrs

24 – 35 lbs

5 mL*

4 – 5 yrs

36 – 47 lbs

7.5 mL

6 – 8 yrs

48 – 59 lbs

10 mL

9 – 10 yrs

60 – 71 lbs

12.5 mL

11 yrs

72 – 95 lbs

15 mL

Other information

store below 30°C (86°F)

Inactive ingredients

benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution

*contains one or more of these ingredients

Questions or comments?

1-800-455-7139 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0537-03

Panadol®

Children’s

ACETAMINOPHEN

160 mg per 5 mL

LIQUID

SPain Reliever

Fever Reducer

EE NEW WARNINGS INFORMATION

Ages 2-11 years

Fast relief of fever and pain

Gentle on your stomach

Ibuprofen free
No sugar added
Aspirin free

artificial

raspberry flavor

4 fl oz (118 mL)

Tamper Evident Feature: Do not use if printed overwrap is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Canada

©2015 GSK

All Rights Reserved.

Keep Carton

102003XB

Panadol Childrens liquid 4 fl oz carton
PANADOL 
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0537
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED (light red) Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0537-01 1 in 1 CARTON 10/15/2012
1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0135-0537-02 1 in 1 CARTON 10/15/2012
2 54.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0135-0537-03 1 in 1 CARTON 10/15/2012
3 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/15/2012
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 1/2016
Document Id: 68821ea6-b4e5-4041-b841-00a8e34dfe26
Set id: e1799765-c247-42b4-ad6a-8ba7d136abf2
Version: 9
Effective Time: 20160108
 
GlaxoSmithKline Consumer Healthcare LP