NON-ASPIRIN ACETAMINOPHEN TABLET [REDICARE LLC]

NON-ASPIRIN ACETAMINOPHEN TABLET [REDICARE LLC]
PDF | XML

NDC 71105-210-68
Set ID 47e01739-bff3-51ef-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Redicare LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Redicare LLC800149346repack(71105-210)

Related Drugs