Label: WHITUBEN- acetaminophen, dextromethorphan hydrobromide hydrate, guaifenesin, pseudoephedrine hydrochloride, triprolidine hydrochloride hydrate capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 18, 2019

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  • ACTIVE INGREDIENT

    Acetaminophen 180mg
    Dextromethorphan Hydrobromide Hydrate 8mg
    DL-Methylephedrine Hydrochloride 12.5mg
    Guaifenesin 20.84mg
    Pseudoephedrine Hydrochloride 15mg
    Triprolidine Hydrochloride Hydrate 0.66mg

  • PURPOSE

    relieve your cold symptoms

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ adult and children 15 years of age and older: 2 capsules three times a day
    ■ children under 15 years of age: ask a doctor

  • WARNINGS

    Warnings
    When using this product
    Do not use for a period longer than 1 weeks
    Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
    fever gets worse or lasts more than 3 days
    New symptoms occur
    These may be signs of a serious condition.
    If pregnant or breast-feeding, ask a health professional before use.
    Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

  • INACTIVE INGREDIENT

    cellulose, corn starch, magnesium stearate, sodium starch glycolate

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    WHITUBEN 
    acetaminophen, dextromethorphan hydrobromide hydrate, guaifenesin, pseudoephedrine hydrochloride, triprolidine hydrochloride hydrate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN180 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN20.84 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg
    METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM) (METHYLEPHEDRINE, (+/-)- - UNII:SHS9PGQ2LS) METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-12.5 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.66 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE8 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code TWLQQ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0037-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/22/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0037) , label(72689-0037)
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