Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 31, 2022

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  • ACTIVE INGREDIENT

    Actives

  • ASK DOCTOR

    Ask a Doctor

  • ASK DOCTOR/PHARMACIST

    Ask a D or P

  • DO NOT USE

    Do Not Use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

    if P or B

  • PURPOSE

    Purposes

  • QUESTIONS

    Questions

  • STOP USE

    Stop Use

  • WHEN USING

    When Using

  • DOSAGE & ADMINISTRATION

    Directions

  • WARNINGS

    Warnings

  • INACTIVE INGREDIENT

    Inactives

  • STORAGE AND HANDLING

    Other Information

  • OVERDOSAGE

    Overdose

  • INDICATIONS & USAGE

    Indications

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69732-007
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeCAPSULESize17mm
    FlavorImprint Code HT565
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69732-007-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/09/2020
    Labeler - Hi-Tech Nutraceuticals, LLC (606221443)
    Registrant - Hi-Tech Nutraceuticals, LLC (606221443)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Nutraceuticals, LLC080787135pack(69732-007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Nutraceuticals, LLC606221443manufacture(69732-007)
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