Label: TENSION HEADACHE ASPIRIN FREE- acetaminophen, caffeine tablet, film coated

  • NDC Code(s): 59779-824-06, 59779-824-08, 59779-824-12, 59779-824-21
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2023

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    (formulated with 65 mg caffeine)

  • Purpose

    Pain reliever

  • 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 4,000 mg of acetaminophen in 24 hours
    • 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:

    • blisters
    • rash
    • skin reddening

    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 heart beat.

    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

    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

    • 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
    • adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
    • children under 12 years: ask a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    corn starch, crospovidone, 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, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS
    Health™

    Compare to the active ingredients
    in Excedrin® Tension Headache*

    Coated Caplets

    Aspirin Free
    Tension Headache

    ACETAMINOPHEN
    & CAFFEINE
    Pain reliever

    100 CAPLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by GSK Consumer Healthcare S.A.,
    owner of the registered trademark Excedrin® Tension Headache.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2020 CVS/pharmacy CVS.com®
    1-800-SHOP CVS V-11112

    50844
    REV1119A42812

    CVS 44-428

    CVS 44-428

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE  ASPIRIN FREE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-824
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;428
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-824-21100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2007
    2NDC:59779-824-06200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2007
    3NDC:59779-824-081 in 1 CARTON01/17/200712/01/2024
    324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59779-824-121 in 1 CARTON01/17/200702/11/2018
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/17/2007
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(59779-824)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(59779-824)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(59779-824)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(59779-824)
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