Label: TENSION HEADACHE RELIEF capsule

  • NDC Code(s): 69168-029-24, 69168-029-26, 69168-029-37, 69168-029-50, view more
    69168-029-98
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2017

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg
    Caffeine 65mg

  • Purpose

    Pain reliever
    Pain reliever aid

  • Uses

    temporary relief of 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 tablets in 24 hours, which is the maximum daily amount

    ■ take with other drugs containing acetaminophen   ■ have 3 or more alcoholic drinks every day while using this product

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:   ■ hives   ■ facial swelling  

    ■ asthma (wheezing)   ■ shock

    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). Ask a doctor or pharmacist before using with other drugs if you are not sure.

    Ask doctor before use if you have

    liver disease

    Stop Use and ask a doctor if

    ■ any new symptoms occur    ■ symptoms do not get better or worsen    ■ 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

    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 PoisonControlCenter immediately. 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 exceed recommended dosage.
    Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
    Children under 12 years: ask a doctor

  • Inactive Ingredients

    corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum  lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Package/Label Principal Display Panel

    Tension Headache

    Tension Headache

    Health A2Z®

    *Compare to the active ingredients in Excedrin® Tension Headache

    See new warnings information

    TENSION HEADACHE RELIEF
    Acetaminophen and Caffeine
    Aspirin Free
    Pain Reliever/Pain Reliever Aid

    Caplets

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    tension headache relief capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-029
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-029-2424 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2014
    2NDC:69168-029-98200 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2014
    3NDC:69168-029-2620 in 1 BOTTLE; Type 0: Not a Combination Product01/20/2020
    4NDC:69168-029-371 in 1 CARTON12/15/2021
    416 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69168-029-5050 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/26/2014
    Labeler - Allegiant Health (079501930)
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