Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

PANADOL EXTRA STRENGTH- acetaminophen tablet, film coated 
PANADOL EXTRA STRENGTH- acetaminophen tablet 
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.

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Active ingredient (in each tablet)

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 (caplets): 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

Liver warning (tablets): This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 tablets 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 severed 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 (Caplets)

• 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

Directions (Tablets)

• do not take more than directed (see overdose warning)
• adults and children 12 years of age and over: take 2 tablets every 6 hours, while symptoms persist or as directed by a doctor
• do not take more than 8 tablets in 24 hours, unless directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• store below 30°C (86°F)

Inactive ingredients (Caplets)

hypromellose, potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc, triacetin

Inactive ingredients (Tablets)

potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc

Questions or comments?

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

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Principal Display Panel

NDC: 0135-0136-04

PANADOL®

EXTRA STRENGTH

500

SEE NEW WARNINGS INFORMATION

ACETAMINOPHEN

Pain Reliever

Fever Reducer

100 CAPLETS

PANADOL and the Beacon design are registered trademarks of 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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in China

©2015 GSK group of companies.

All Rights Reserved.

Keep Carton

101636XB

Principal Display Panel

NDC: 0135-0135-04

PANADOL®

EXTRA STRENGTH

500

SEE NEW WARNINGS INFORMATION

ACETAMINOPHEN

Pain Reliever

Fever Reducer

100 TABLETS

PANADOL and the Beacon design are registered trademarks of 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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in India

©2015 GSK group of companies.

All Rights Reserved.

Keep Carton

101587XB

PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0136
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL (Caplet)	Size	18mm
Flavor		Imprint Code	PANADOL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0136-05	50 in 1 CARTON	03/18/2011	05/31/2019
1	NDC: 0135-0136-09	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0135-0136-01	1 in 1 CARTON	04/18/2011	06/30/2018
2		10 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0135-0136-02	1 in 1 CARTON	03/18/2011	04/30/2019
3		24 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0135-0136-03	1 in 1 CARTON	03/18/2011	04/30/2019
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0135-0136-04	1 in 1 CARTON	03/18/2011	12/31/2018
5		100 in 1 BOTTLE; 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	03/18/2011	05/31/2019

PANADOL  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0135
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
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	PANADOL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0135-05	50 in 1 CARTON	03/18/2011	11/30/2018
1	NDC: 0135-0135-07	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0135-0135-02	1 in 1 CARTON	03/18/2011	04/30/2017
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0135-0135-03	1 in 1 CARTON	03/18/2011	12/31/2016
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0135-0135-04	1 in 1 CARTON	03/18/2011	12/31/2016
4		100 in 1 BOTTLE; 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	03/18/2011	11/30/2018

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

Revised: 11/2016

Document Id: 45fc4a8a-26e0-44a5-8033-50dfc8978a13

Set id: 62920a3f-c662-4db2-a4aa-8170a23ed3b6

Version: 10

Effective Time: 20161104

 

GlaxoSmithKli