Label: TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet

  • NDC Code(s): 33992-0428-5, 33992-0428-8
  • Packager: GREENBRIER INTERNATIONAL, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/15

If you are a consumer or patient please visit this version.

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    (formulated with 65 mg caffeine)

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  • Purpose

    Pain reliever

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  • Uses

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

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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 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

    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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • symptoms do not get better or worsen

    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: In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 children12 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
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • 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 

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  • Questions or comments?

     1-800-426-9391

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  • Principal Display Panel

    Assured™ 

    COMPARE TO ACTIVE INGREDIENTS OF
    EXCEDRIN® TENSION HEADACHE*

    Tension Headache Relief 

    • Acetaminophen 500 mg
      Caffeine 65 mg
      Pain Reliever / Pain reliever aid 

    Actual Size

    24 caplets

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

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Tension Headache.
    50844    REV0615D42808

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY
    CHESAPEAKE, VA 23320

    Assured 44-428

    Assured 44-428


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  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0428
    Route of Administration ORAL DEA Schedule     
    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
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code 44;428
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-0428-5 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:33992-0428-8 1 in 1 CARTON
    2 24 in 1 BOTTLE, PLASTIC; 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 01/17/2007
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(33992-0428)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(33992-0428)
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