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:

GSKConsumer Healthcare, Warren, NJ 07059

101596D

101596XD_Panadol Extra Strength 500_24 ct.JPG

PANADOL EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0609
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Caplet)	Size	17mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0609-01	1 in 1 CARTON	03/15/2017
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0135-0609-02	1 in 1 CARTON	03/15/2017
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0135-0609-03	1 in 1 CARTON	03/15/2017
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:0135-0609-04	50 in 1 CARTON	03/15/2017
4	NDC:0135-0609-05	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	03/15/2017

Labeler - Haleon US Holdings LLC (079944263)

Drug Facts