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

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

PANADOL EXTRA (ACETAMINOPHEN AND CAFFEINE) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0620-01
Set ID e5c2d88a-d903-4ca0-b895-f27e791dfc4e
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

    Caffeine 65 mg

  • Purposes

    Pain reliever

    Pain reliever aid

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    headache
    •
    muscular aches
  • 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: acetaminophen 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.

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

    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, caffeine or any of the other 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 occur

    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 use more than directed (see overdose warming)
    •
    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: ask a doctor
  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    close cap tightly after use
  • Inactive ingredients

    benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc titanium dioxide

  • Questions or comments?

    1-800-455-7139

  • Principal Display Panel

    NDC 0135-0620-01

    Panadol®

    EXTRA

    ACETAMINOPHEN

    Pain Reliever

    CAFFEINE

    Pain Reliever Aid

    NEW

    24 CAPLETS

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2016 GSK group of companies or its licensor. All rights reserved.

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

    62000000011138

    C:\Users\sh821028\Panadol_Caplets_24 count_carton.jpg
  • INGREDIENTS AND APPEARANCE
    PANADOL  EXTRA
    acetaminophen and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVAL (Caplet) Size17mm
    FlavorImprint Code ETH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0620-011 in 1 CARTON03/01/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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