Label: CLEAR CHOICE REGULAR 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 325 mg

  • Purposes

    Pain reliever / fever reducer

  • Uses

    temporary relief of minor aches and pains associated with

    • the 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 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks ever day while using this product

    Allergy alert: Acetaminophen may cause sever 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

    • 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

    user has liver disease

  • Ask a doctor or pharmacist before use if

    the user is 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
    • pain gets worse or lasts more than 5 days in children under 12
    • 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,

    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

    Adults and children 12 years of age and older:

    Take 2 tablets every 4 to 6 hours as needed.

    Do not take more than 10 tablets in 24 hours 

    Children 6 to 11 years of age: Take 1 tablet every 4 to 6 hours as needed

    Do not take more than 5 tablets in 24 hours

    Children under 6 years of age:

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

  • Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • 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

    Regular Strength

    PAIN RELIEVER

    ACETAMINOPHEN

    PAIN & FEVER RELIEF

    CONTAINS NO ASPIRIN

    CAFFEINE FREE

    Compare to Regular Strength Tylenol (R)

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AZ234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53185-005-00100 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/03/2013
    Labeler - Athlete's Needs, Inc. (619703945)
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