Label: NON-ASPIRIN ACETAMINOPHEN 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 July 2, 2021

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

  • Active Ingredient (in each tablet) ..................................................... Purpose

    Acetaminophen 500 mg .....................................................................................pain reliever/fever reducer

  • Uses:

    temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache

  • Warnings:

    Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.

  • Do not use:

    ■ with any other product containing acetaminophen ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor

  • When using this product do not exceed recommended dose.

  • Stop use and ask a doctor if

    ■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present

  • If pregnant or breast-feeding a baby,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    In a 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:

    Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
    Children under 12 years of age: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

  • Other Information:

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) • Avoid excessive heat and humidity

  • Inactive Ingredients:

    corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

  • PRINCIPAL DISPLAY PANEL

    Non Aspirin

  • INGREDIENTS AND APPEARANCE
    NON-ASPIRIN ACETAMINOPHEN 
    non-aspirin acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-210-68100 in 1 CARTON; Type 0: Not a Combination Product10/01/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/01/2017
    Labeler - Redicare LLC (800149346)