Label: PANADOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 0135-0609-01, 0135-0609-02, 0135-0609-03, 0135-0609-04, view more
    0135-0609-05
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • 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

    ©2016 GSK group of companies or its licensor.

    101596D

    101596XD_Panadol Extra Strength 500_24 ct.JPG
  • INGREDIENTS AND APPEARANCE
    PANADOL   EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0609
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVAL (Caplet) Size17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0609-011 in 1 CARTON03/15/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0135-0609-021 in 1 CARTON03/15/2017
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0135-0609-031 in 1 CARTON03/15/2017
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0135-0609-0450 in 1 CARTON03/15/2017
    4NDC:0135-0609-052 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/15/2017
    Labeler - Haleon US Holdings LLC (079944263)
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