PANADOL  EXTRA STRENGTH- acetaminophen tablet, film coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

Warnings

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

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Other information

Inactive ingredients

castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

1-800-455-7139

Principal Display Panel

NDC 0135-7011-04

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

100 CAPLETS

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2020 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

B-0630-764-12 Front Carton

B-0630-764-12_Panadol ES 500 100 ct
PANADOL   EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-7011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Caplet) Size17mm
FlavorImprint Code PAN;ES
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-7011-031 in 1 CARTON02/15/2021
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0135-7011-041 in 1 CARTON03/19/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0135-7011-012 in 1 POUCH; Type 0: Not a Combination Product06/11/2021
4NDC:0135-7011-021 in 1 CARTON06/08/2021
424 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/15/2021
Labeler - Haleon US Holdings LLC (079944263)

Revised: 2/2024
Document Id: 10c12d49-cd3c-e104-e063-6294a90a4e5a
Set id: 9d384e88-5c11-4600-ac6c-a38371570138
Version: 8
Effective Time: 20240206
 
Haleon US Holdings LLC