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Regular Strength Pain Reliever (Athlete's Needs Inc)

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TABLET 100 TABLET in 1 BOTTLE (53185-005-00) Label Information

Complete Regular Strength Pain Reliever Information

  • Active Ingredient (in each tablet)

    Acetaminophen 325 mg


  • Purposes

    Pain reliever / fever reducer


  • Uses

    temporary relief of minor aches and pains associated with

    • common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • arthritis
    • premenstrual and menstrual cramps
    • temporarily reduces 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
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks ever day while using this product

  • 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.


  • Ask a doctor before use if you have

    liver disease


  • Ask a doctor or pharmacist before use if you

    are taking 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 800-326-8147

  • If pregnant or breast-feeding,

    ask a health professional before use


  • Keep out of reach of children.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

    Do not exceed recommended dosage.


  • Directions

    Adults and children 12 years of age and older

    Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

    Children under 12 years of age

    Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.


  • Other information

    store at room temperature

    do not use if imprinted safety seal under cap is broken or missing


  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.


  • SPL UNCLASSIFIED SECTION

    This product not manufactured or distributed by McNeil-Consumer Healthcare Co., owner of the trademark Tylenol(R).


  • Package Label

    Clear Choice

    Regular Strength

    PAIN RELIEVER

    ACETAMINOPHEN

    PAIN AND FEVER RELIEF

    CONTAINS NO ASPIRIN

    CAFFEINE FREE

    Compare to Extra Strength Tylenol (R)

    See new warnings information

    100 Tablets

    325 mg Each

    Questions?
    Contact A.N.I. 6029 Renaissance Place, Toledo OH 43623
    Manufactured for A.N.I.

    Label1

    Label2


  • INGREDIENTS AND APPEARANCE
    CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53185-005
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code AZ234
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53185-005-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/03/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/03/2013
    Labeler - Athlete's Needs Inc (619703945)
    Establishment
    Name Address ID/FEI Business Operations
    Allegiant Health 079501930 manufacture(53185-005)