Medication Guide App

← See all PANADOL Extra Strength brands

PANADOL Extra Strength by GlaxoSmithKline Consumer Healtcare LP

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: GlaxoSmithKline Consumer Healtcare LP
NDC Code: 0135-0239

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
menstrual cramps
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

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 you have
liver disease
a sodium-restricted diet

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
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
each caplet contains: sodium 173 mg
store below 30°C (86°F)

Inactive ingredients

carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, purified water, sodium bicarbonate, starch, titanium dioxide, triacetin

Questions or Comments?

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

Principal Display Panel

NDC 0135-0239-02

Panadol®

EXTRA STRENGTH

Liberación Rápida  

ACETAMINOPHEN

Pain Reliever

Fever Reducer

20 Caplets

Read and keep 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.

©2011 GlaxoSmithKline

Made in China

101602XA

PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0239
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POTASSIUM SORBATE 
POVIDONES 
STARCH, CORN 
WATER 
SODIUM BICARBONATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Capsule) Size19mm
FlavorImprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0239-0110 TABLET, FILM COATED in 1 BOTTLE
2NDC:0135-0239-0220 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/18/2011
Labeler - GlaxoSmithKline Consumer Healtcare LP (828924212)

Revised: 03/2013
 
GlaxoSmithKline Consumer Healtcare LP

← See all PANADOL Extra Strength brands

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.

Hide
(web2)