SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [DENISON PHARMACEUTICALS, LLC.]

SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [DENISON PHARMACEUTICALS, LLC.]
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NDC 0295-5307-17, 0295-5307-28
Set ID 3d6e56ad-d31b-4ef6-9690-f18b1ee45664
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 5ml tsp)Purpose
    Dextromethorphan HBr,USP 7.5 mgCough Suppressant
    Doxylamine Succinate, USP 3.125 mg Expectorant
  • USES

    Cough Suppressant


    Antihistamine

  • 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

    agedose
    adults and children
    12 years and over
    4 teaspoons
    every 6 hours
    children 4 to 12 yearsask a doctor
    children under 4 yearsdo 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. 

  • Ask a Doctor

    Before you use if you have:

    • Asthma
    • emphysema
    • glaucoma
    • excessive phlem (mucus)
    • breathing problem
    • chronic bronchitis
    • persisten or chronic cough
    • cough associated with smoking
    • trouble urinating do to enlarged prostate gland
    • a sodium restricted diet
  • ASK DOCTOR/PHARMACIST

    If you are taking sedatives or tranquilizers.

  • WHEN USING

    • do not use more than directed
    • excitability may occur, specially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driing
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase drowsiness
  • STOP USE

    Ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

  • OTHER INFORMATION

    • Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
    • Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

    Safe this package for complete information

  • SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID

    label

  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN  PM
    dextromethorphan doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-5307
    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, UNSPECIFIED FORM (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:0295-5307-171 in 1 CARTON01/01/2017
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0295-5307-281 in 1 CARTON01/01/201711/07/2019
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2017
    Labeler - Denison Pharmaceuticals, LLC. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC.001207208manufacture(0295-5307)

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