PANADOL EXTRA STRENGTH- acetaminophen tablet, film coated

PANADOL by

Drug Labeling and Warnings

PANADOL by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0609
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/15/2017

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