Label: ACETAMINOPHEN tablet, coated

  • NDC Code(s): 49035-755-50, 49035-755-88
  • Packager: WAL-MART STORES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 19, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient (in each caplet)

    acetaminophen 500 mg

  • INACTIVE INGREDIENT

    inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*stearic acid, titanium dioxide
    *may contain

  • PURPOSE

    PAIN RELIEVER - FEVER REDUCER

  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed (see overdose warning)

    adults and children 12 years and over: take 2 caplets every 4 to 6 hours while symptoms last

    do not take more than 6 caplets in 24 hours

    do not take for more than 10 days unless directed by a doctor

    children under 12 years: ask a doctor.

  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps, temporarily reduces fever.

  • WARNINGS

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    341r 2X500 sleeve

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-755
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code TCL341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-755-881000 in 1 PACKAGE01/03/2020
    1NDC:49035-755-50500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/03/2020
    Labeler - WAL-MART STORES INC (051957769)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(49035-755)
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