PANADOL- 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
•: 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: acetaminophen 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 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

•: each caplet contains: calcium 25 mg
•: store below 30°C (86°F)

Inactive ingredients

alginic acid, calcium carbonate, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium ethylparaben, sodium methylparaben, sodium propylparaben, titanium dioxide

Questions or comments?

1-800-455-7139 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0507-06

Panadol®

Advance

WITH OPTI ZORB FORMULATION®

ACETAMINOPHEN

SEE NEW WARNINGS INFORMATION

Pain Reliever

Fever Reducer

100 CAPLETS

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

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

Keep Carton

101997XB

Panadol Advanced 100 count caplets carton

PANADOL
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0507
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
ALGINIC ACID (UNII: 8C3Z4148WZ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM ETHYLPARABEN (UNII: Z0D00IVA10)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL (caplet)	Size	17mm
Flavor		Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0507-02	50 in 1 CARTON	06/21/2011	05/31/2017
1	NDC:0135-0507-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:0135-0507-04	1 in 1 CARTON	06/21/2011	04/30/2017
2		20 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0135-0507-05	1 in 1 CARTON	06/21/2011	04/30/2017
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:0135-0507-06	1 in 1 CARTON	06/21/2011	04/30/2017
4		100 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	06/21/2011	05/31/2017

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

Revised: 11/2016

Document Id: 34aebb99-6e78-4624-aef6-8b95c13f6123

Set id: d7a6b21b-5680-464c-9576-e90ffb2564f1

Version: 9

Effective Time: 20161104

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC