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PANADOL Extra Strength

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0136

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 caplet)

Acetaminophen 500 mg

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses
temporarily relieves minor aches and pains due to:
headache
backache
muscular aches
minor arthritis pain
temporarily reduces fever

Warnings

Liver warning (caplets): This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Liver warning (tablets): This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severed 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 a 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 you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if
pain gets worse or lasts more than 10 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.

If pregnant or breast-feeding,

ask a health professional before use.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions (Caplets)
do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
do not take more than 8 caplets in 24 hours, unless directed by a doctor
children under 12 years of age: ask a doctor

Directions (Tablets)
do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 tablets every 6 hours, while symptoms persist or as directed by a doctor
do not take more than 8 tablets in 24 hours, unless directed by a doctor
children under 12 years of age: ask a doctor

Other information
store below 30°C (86°F)

Inactive ingredients (Caplets)

hypromellose, potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc, triacetin

Inactive ingredients (Tablets)

potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc

Questions or comments?

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

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Principal Display Panel

NDC 0135-0136-04

PANADOL®

EXTRA STRENGTH

500

SEE NEW WARNINGS INFORMATION

ACETAMINOPHEN

Pain Reliever

Fever Reducer

100 CAPLETS

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

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in China

©2015 GSK group of companies.

All Rights Reserved.

Keep Carton

101636XB

Principal Display Panel

NDC 0135-0135-04

PANADOL®

EXTRA STRENGTH

500

SEE NEW WARNINGS INFORMATION

ACETAMINOPHEN

Pain Reliever

Fever Reducer

100 TABLETS

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

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in India

©2015 GSK group of companies.

All Rights Reserved.

Keep Carton

101587XB

PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POTASSIUM SORBATE 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
TALC 
TRIACETIN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (Caplet) Size18mm
FlavorImprint CodePANADOL
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0136-0550 PACKET in 1 CARTON
1NDC:0135-0136-092 TABLET, FILM COATED in 1 PACKET
2NDC:0135-0136-011 BOTTLE in 1 CARTON
210 TABLET, FILM COATED in 1 BOTTLE
3NDC:0135-0136-021 BOTTLE in 1 CARTON
324 TABLET, FILM COATED in 1 BOTTLE
4NDC:0135-0136-031 BOTTLE in 1 CARTON
450 TABLET, FILM COATED in 1 BOTTLE
5NDC:0135-0136-041 BOTTLE in 1 CARTON
5100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/18/201105/31/2019
PANADOL  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0135
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
TALC 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint CodePANADOL
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0135-0550 PACKET in 1 CARTON
1NDC:0135-0135-072 TABLET in 1 PACKET
2NDC:0135-0135-021 BOTTLE in 1 CARTON
230 TABLET in 1 BOTTLE
3NDC:0135-0135-031 BOTTLE in 1 CARTON
360 TABLET in 1 BOTTLE
4NDC:0135-0135-041 BOTTLE in 1 CARTON
4100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/18/201111/30/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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