Label: SAFETUSSIN DM - dextromethorpan guaifenesin liquid

  • 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 February 8, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each 5ml tsp) Purpose
    Dextromethorphan HBr,USP 10 mg Cough Suppressant
    Guaifenesin, USP 100 mg Expectorant
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  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation
    • loosens phlegm (mucus)
    • helps rid bronchial passages of phlegm (mucus)
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  • 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.

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  • Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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  • STOP USE

    Stop use and 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 a serious condition.

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  • NURSING MOTHERS

    If pregnant or breast-feeding, ask a health professional before use.

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  • 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.

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  • Directions

    • do not take more than 6 doses in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    age dose
    adults and children
    12 years and over
    2 teaspoons
    every 4 hours
    children under 12 years do not use
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  • Other information:

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

    Save this package for complete information

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  • INACTIVE INGREDIENT

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

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  • PRINCIPAL DISPLAY PANEL

    Safetussin® DM 
    DAY TIME COUGH RELIEF

    COUGH SUPPRESSANT/ EXPECTORANT
    Relieves Cough
    Loosens Mucus

    SAFE For Those With:
    High Blood Pressure
    Diabetes

    SUGAR FREE

    Dye Free
    Gluten Free
    Alcohol Free

    4 FL. OZ (120 ml.)

    Safetussin® DM 

    Alivia la tos
    Descongestiona el Pecho

    SEGURO para los que padecen de:
    Presión alta
    Diabetes

    SIN AZÚCAR

    Sin Colorantes
    Sin Gluten
    Sin Alcohol

    4 FL. OZ (120 ml.)

    NON-DROWSY

    Safe Cough Relief
    Pure and Simple

    Safetussin® was developed by a pharmacist who recognized the special needs of many of his customers afflicted with high blood pressure, diabetes, and those looking for simple, safe cough relief.

    Safetussin is specially formulated, free of alcohol, sugar, dyes, decongestants and other unwanted ingredients that are not needed for safe, adult strength cough treatment.

    The Clear Choice!

    Pharmacist Recommended

    Dosage Cup Included
    Vaso Dosificador Incluido

    Distributed by/ Distribuido por
    KRAMER
    CONSUMER HEALTHCARE
    A division of Kramer Laboratories

    www.safetussin.com
    www.kramerconsumerhealthcare.com

    Coral Gables, FL 33134
    1-800-824-4894

    k0916

    carton

    Safetussin® DM 
    DAY TIME COUGH RELIEF

    COUGH SUPPRESSANT/ EXPECTORANT

    High Blood Pressure
    Diabetes

    4 FL. OZ. (120 mL)

    KRAMER
    CONSUMER HEALTHCARE
    A division of Kramer Laboratories

    Coral Gables, FL 33134
    www.kramerlabs.com
    www.safetussin.com

    k0916

    label
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  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN  DM
    dextromethorpan guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-111
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Aspartame (UNII: Z0H242BBR1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    MINT (UNII: FV98Z8GITP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55505-111-33 1 in 1 CARTON 02/10/2017
    1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/29/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    Name Address ID/FEI Business Operations
    Denison Pharmecuticals 001207208 manufacture(55505-111)
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