Your browser does not support JavaScript! PANADOL (ACETAMINOPHEN) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]
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PANADOL (acetaminophen) liquid
[GlaxoSmithKline Consumer Healthcare LP]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient (in each ½ teaspoon)(0135-0138)

Acetaminophen 80 mg

Active ingredient (in each 5mL)(0135-0537)

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

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.

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 overdose, 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: (0135-0138)

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

do not take more than directed (see overdose warning)
if needed, repeat dose every 4 hours while symptoms persist
do not take more than 5 doses in 24 hours, unless directed by a doctor
use enclosed pre-marked measuring cup for accuracy*
may be administered alone or mixed with formula, milk or juice

Age

Weight

Dosage

under 2 yrs

under 24 lbs

ask a doctor

2 - 3 yrs

24 – 35 lbs

1 teaspoon

4 – 5 yrs

36 – 47 lbs

1 ½ teaspoons

6 – 8 yrs

48 – 59 lbs

2 teaspoons

9 – 10 yrs

60 – 71 lbs

2 ½ teaspoons

11 yrs

72 – 95 lbs

3 teaspoons

*TSP=teaspoon on measuring cup

Directions: (0135-0537)

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

*mL=milliliter

Other information

store below 30°C (86°F)

Inactive ingredients (0135-0138)

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

*contains one or more of these ingredients

Inactive ingredients (0135-0537)

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?

1-800-981-3511 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0138-01

PANADOL®

Children

ACETAMINOPHEN

LIQUID

Pain Reliever

Fever Reducer

For ages 2 to 11

Fast relief of fever and pain

Gentle on your stomach

No sugar added
Aspirin free
Ibuprofen free

artificial

raspberry flavor

2 fl oz Liquid

80 mg in each 1/2 teaspoon

Read and retain carton for complete information

Tamper Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Made in China

©2011 GlaxoSmithKline

100654XB

Panadol Children Liquid 2 fl oz carton

Principal Display Panel

NDC 0135-0537-03

Panadol®

Children’s

ACETAMINOPHEN

LIQUID

Pain Reliever

Fever Reducer

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)

160 mg in each 5 mL

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

Read and keep carton for complete information

PANADOL is a registered trademark of the GlaxoSmithKline group of companies.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Made in Canada

©2012 GlaxoSmithKline

102003XA (A103640)

Panadol Childrens liquid 4 fl oz carton
PANADOL 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0138
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HYDROCHLORIC ACID 
POLYETHYLENE GLYCOLS 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0138-011 in 1 CARTON
160 mL in 1 BOTTLE
2NDC:0135-0138-021 in 1 CARTON
2120 mL in 1 BOTTLE
3NDC:0135-0138-0315 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/03/201108/01/2013
PANADOL 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0537-011 in 1 CARTON
115 mL in 1 BOTTLE
2NDC:0135-0537-021 in 1 CARTON
254.7 mL in 1 BOTTLE
3NDC:0135-0537-031 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 LP (828924212)

Revised: 4/2013
 
GlaxoSmithKline Consumer Healthcare LP

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