Label: EXCEDRIN TENSION HEADACHE- acetaminophen, caffeine tablet, film coated

  • NDC Code(s): 0067-8139-01, 0067-8139-02
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated March 13, 2018

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 65 mg

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  • Purposes

    Pain reliever

    Pain reliever aid

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  • Uses

    temporarily relieves minor aches and pain due to:
    headache
    muscular aches
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  • Warnings

    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.

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

    more than 6 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

    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

    if you are allergic to acetaminophen
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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

    any new symptoms occur
    painful area is red or swollen
    pain gets worse or lasts for more than 10 days
    fever gets worse or lasts for more than 3 days

    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.

    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.

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  • Directions

    do not use more than directed
    adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
    children under 12 years: ask a doctor
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  • Other information

    store at 20°-25°C (68°-77°F)
    close cap tightly after use
    read all product information before using. Keep this box for important information.
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  • 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

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  • Questions or comments?

    1-800-452-0051

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  • Principal Display Panel

    NDC 0067-8139-02

    EXCEDRIN®

    TENSION HEADACHE

    Acetaminophen and Caffeine

    Pain Reliever / Pain Reliever Aid

    Aspirin Free

    100 CAPLETS

    TAMPER-EVIDENT BOTTLE

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

    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

    Visit us at www.excedrin.com

    46177300

    46177300_Excedrin Tension Headache_100 ct.JPG
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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  TENSION HEADACHE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8139
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL ((Caplet)) Size 17mm
    Flavor Imprint Code ETH
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-8139-01 1 in 1 CARTON 12/15/2016
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0067-8139-02 1 in 1 CARTON 12/15/2016
    2 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/15/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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