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PANADOL Extra Strength by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on April 17, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0609

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

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: 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

Allergy alert: A‑cetaminophen 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 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
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

Other information
store below 25°C (77°F)

Inactive ingredients

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-455-7139

Principal Display Panel

NDC 0135-0609-01

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

24 CAPLETS

Trademarks are owned by or licensed to 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

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

©2016 GSK group of companies or its licensor.

101596D

PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0609
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Caplet) Size17mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0609-011 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
2NDC:0135-0609-021 BOTTLE in 1 CARTON
250 TABLET, FILM COATED in 1 BOTTLE
3NDC:0135-0609-031 BOTTLE in 1 CARTON
3100 TABLET, FILM COATED in 1 BOTTLE
4NDC:0135-0609-0450 PACKET in 1 CARTON
4NDC:0135-0609-052 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/15/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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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