Label: CLEAR CHOICE EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2018

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  • Active Ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purposes

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with

    • common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen.

    • Severe liver damage may occur if
    • adult takes more than 4,000mg of acetaminophen in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 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 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 (1-800-222-1222) 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

    do not use more than directed (see overdose warning)

    Do not use more than 10 days unless directed by a doctor

    • adults and children 12 years and over: take two tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
    • 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
  • Other information

    • store between 59º-86ºC (15º-30ºF)
    • 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

  • Package Label

    Clear Choice

    Extra Strength

    PAIN RELIEVER

    ACETAMINOPHEN

    PAIN & FEVER RELIEF

    CONTAINS NO ASPIRIN

    CAFFEINE FREE

    Compare to Extra Strength Tylenol (R)

    See new warnings information

    100 Tablets

    500 mg Each

    Questions? Contact A.N.I. Toledo OH

    Manufactured for A.N.I. Toledo OH 436253

    Acetaminophen 500mg

    Acetaminophen 500mg




  • INGREDIENTS AND APPEARANCE
    CLEAR CHOICE EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-002
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Colorwhite (micro-filmed coated white) Scoreno score
    ShapeROUND (round, standard convex) Size12mm
    FlavorImprint Code AZ235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53185-002-00100 in 1 BOTTLE; Type 0: Not a Combination Product09/13/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/13/2012
    Labeler - Athlete's Needs, Inc. (619703945)
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