PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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  • PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0609-01, 0135-0609-02, 0135-0609-03, 0135-0609-04, 0135-0609-05
Set ID b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART343
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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:

    GSK Consumer 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 not finalpart34303/15/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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