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

Panadol Extra Strength 100 caplet carton

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 100 Tablet carton
PANADOL  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0136
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeOVAL (Caplet) Size18mm
FlavorImprint Code PANADOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0136-0550 in 1 CARTON03/18/201105/31/2019
1NDC:0135-0136-092 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0135-0136-011 in 1 CARTON04/18/201106/30/2018
210 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0135-0136-021 in 1 CARTON03/18/201104/30/2019
324 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0135-0136-031 in 1 CARTON03/18/201104/30/2019
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0135-0136-041 in 1 CARTON03/18/201112/31/2018
5100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/18/201105/31/2019
PANADOL  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code PANADOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0135-0550 in 1 CARTON03/18/201111/30/2018
1NDC:0135-0135-072 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0135-0135-021 in 1 CARTON03/18/201104/30/2017
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0135-0135-031 in 1 CARTON03/18/201112/31/2016
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0135-0135-041 in 1 CARTON03/18/201112/31/2016
4100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/18/201111/30/2018
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
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC