Label: ACETAMINOPHEN 500MG CAFFEINE 65MG tablet

  • NDC Code(s): 70692-110-41
  • Packager: Strive Pharmaceuticals Inc
  • 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 20, 2018

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

  • ACTIVE INGREDIENT

    Acetaminophen 500mg; Caffeine 65mg

  • INACTIVE INGREDIENT

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide

  • DOSAGE & ADMINISTRATION

    • take with a full glass of water
    • do not take more than directed
    • do not take more than 6 caplets in 24 hours
    adults and children 12 years of age and overtake 2 caplets every 6 hours, not more than 6 caplets in 24 hours
    children under 12 years of ageask a doctor

  • INDICATIONS & USAGE

    *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 6 caplets in 24 hours, which is the maimum daily amount
    • 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:

    • 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 takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.

    Do not use

    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or non prescription). 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 a pharmacist before use if

    you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • new symptoms occur
    • painful area is red or swollen

    These could be signs of a serious comdition

    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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: 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.

  • PURPOSE

    Pain reliever ; Pain reliever aid

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • PRINCIPAL DISPLAY PANEL

    CT11041

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500MG CAFFEINE 65MG 
    acetaminophen 500mg caffeine 65mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-110
    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
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code S777
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-110-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/20/2018
    Labeler - Strive Pharmaceuticals Inc (080028013)