Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL

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 February 14, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Acetaminophen 325mg

    Acetaminophen 500mg

  • PURPOSE

  • Keep Out of Reach of Children

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as children, even if you do not notice symptoms or signs.

  • Uses

    Use for temporary relief of minor aches and pains due to:

    ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever

  • Warnings

    Alcohol Warning: If you consume 3 or more alcoholic beverages every day, ask your doctor whether you should take Acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Do not use with any other product containing Acetaminophen or if you have ever had an allergic reaction to pain relievers/fever reducers.

    Stop use and ask a doctor if

    ° new symptoms occur ° redness or swelling is present ° pain gets worse or lasts more than 10 days ° fever gets worse or lasts more than 3 days.

    If pregnant or breast-feeding, ask a doctor before use.

  • Directions

    Do not take more than directed

    ° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.

  • Other Information

    For your protection, this bottle has an imprinted Safety Seal under cap. Do not use if Safety Seal is broken or missing.

    Store at room temperature.

    Questions? To report an adverse drug effect, contact 1-800-795-9775.

  • Inactive ingredients

    Crospovidone, Povidone, Pregelatinized Starch, Stearic Acid.

    Distributed by:

    Plus PharmaCommack

    New York 11725

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Principal Display Panel

    Acetaminophen 325mg

  • Principal Display Panel

    Acetaminophen 500mg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-007(NDC:51645-703)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-007-3030 in 1 BOTTLE
    2NDC:21695-007-6060 in 1 BOTTLE
    3NDC:21695-007-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2007
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-008(NDC:51645-706)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize14mm
    FlavorImprint Code GPI;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-008-1414 in 1 BOTTLE
    2NDC:21695-008-1515 in 1 BOTTLE
    3NDC:21695-008-2020 in 1 BOTTLE
    4NDC:21695-008-3030 in 1 BOTTLE
    5NDC:21695-008-5050 in 1 BOTTLE
    6NDC:21695-008-6060 in 1 BOTTLE
    7NDC:21695-008-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2007
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK