SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [KRAMER LABORATORIES]

SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [KRAMER LABORATORIES]
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NDC 55505-190-36
Set ID da5c218f-685c-4862-b532-9b525259663b
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Dextromethorphan

    Doxylamine Succinate

  • PURPOSE

    Cough Suppressant


    Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of
    overdose, get medical help or contact a Poison
    Control Center right away

  • INDICATIONS & USAGE

    • temporarily relieves coughgh • runny nose and sneezing
  • DOSAGE & ADMINISTRATION

    Do not take more than 4 doses in any 24- hours period.
    adults and children12 years and over 4 teaspoons every 6 hours
    children 4 to 12 years ask a doctor
    children under 4 years do not use

  • INACTIVE INGREDIENT


     aspartame,benzoic acid,citric acid,glycerin,menthol,methylparaben,natural peppermint flavor,propylene glycol,propylparaben
     purified water

  • WARNINGS

    Do not use
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN   PM
    dextromethorphan doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE3.125 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aspartame (UNII: Z0H242BBR1)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    menthol (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    MINT (UNII: FV98Z8GITP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-190-36240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2015
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(55505-190)

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