Label: ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER- 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 16, 2019

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

  • Drug Facts

  • Active ingredients (in each tablet)

    Acetaminophen 500mg

    Caffeine 65mg

    Purpose

    Pain Reliever- Fever Reducer

    Analgesic Adjuvant

  • Uses

    • For the temporary relief of minor aches and pains associated with headache and to reduce fever.
  • 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 for this product • 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.

    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.

    • for more than 10 days for pain unless directed by a doctor

    • for more than 3 days for fever unless directed by a doctor

    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 • redness or swelling is present. 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 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

    • Take 1 tablet every 3-4 hours, while symptoms persist, or as directed by a doctor

    • Do not exceed 8 tablets in 24 hours

    • Children under 12 years of age: consult a doctor

  • Other information

    • store at room temperature (59-86°F/15-30°C

    • do not use if inner mouth seal is broken

  • Inactive ingredients

    Colloidal Silicon Dioxide, Cornstarch, Ethylparaben, FD&C Red No. 40, FD&C Yellow No. 6, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Propylparaben, Sodium Carboxymethyl Starch, Sodium Starch Glycolate, Stearic Acid, Sucralose, Talc, Titanium Dioxide

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62049-002
    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)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 104
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62049-002-00100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/05/2016
    Labeler - Genvion Corporation (245221226)