PAIN RELIEF EASY TO SWALLOW EXTRA STRENGTH EASY TO SWALLOW (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]

PAIN RELIEF EASY TO SWALLOW EXTRA STRENGTH EASY TO SWALLOW (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]
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NDC 69168-353-99
Set ID 3329f052-a069-4a36-a3be-882f55a0f831
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporary relief of minor aches and pains associated with
    • common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • arthritis
    • menstrual cramps
    • and reduction of fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4000 mg of acetaminophen in 24 hours, which is the maximum 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.

    Do not use

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

    are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • symptoms do not improve
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • a rare sensitivity reaction occurs
    • You may report side effects to 1-888-952-0050
  • If pregnant or breast-feeding

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

  • Keep Out of Reach of Children

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • Directions

    • do not use more than directed (see overdose warning)
    • adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
    • Do not use more than 10 days unless directed by a doctor
    • children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
  • Inactive Ingredients

    carnauba wax, FD&C red#40 aluminum lake, hypromellose, polyethylene glycol 400, polyethylene glycol 8000, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, titanium dioxide

  • Package/Label Principal Display Panel

    Acetaminophen 500 mg

    Acetaminophen 500 mg

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF EASY TO SWALLOW  EXTRA STRENGTH EASY TO SWALLOW
    acetaminophen 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code TCL342
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-353-991 in 1 CARTON12/17/2014
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/17/2014
    Labeler - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930LABEL(69168-353) , PACK(69168-353)

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