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PANADOL by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on August 9, 2017

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0537

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.

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 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0537
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HYDROCHLORIC ACID 
POLYETHYLENE GLYCOLS 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorRED (light red) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0537-011 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
2NDC:0135-0537-021 BOTTLE in 1 CARTON
254.7 mL in 1 BOTTLE
3NDC:0135-0537-031 BOTTLE in 1 CARTON
3118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/15/2012
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

See Also

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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