Label: SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid

  • NDC Code(s): 0295-5307-17, 0295-5307-28
  • Packager: Denison Pharmaceuticals, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 7, 2019

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  • 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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