PANADOL EXTRA STRENGTH- acetaminophen tablet, film coated
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

Made in China

101602XA

Panadol Liberacion Rapida 20 count carton

PANADOL EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0239
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (Capsule with flat edges)	Size	19mm
Flavor		Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0239-01	1 in 1 CARTON	03/18/2011	02/28/2015
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0135-0239-02	1 in 1 CARTON	03/18/2011	10/31/2016
2		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/18/2011	10/31/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2016

Document Id: 2d5490f5-b05a-44d3-bb36-ef4a655d91b0

Set id: 2e107055-c2cf-4a71-a60a-14a73073dd01

Version: 5

Effective Time: 20160802

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC