Label: SAFETUSSIN DM- dextromethorpan guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • ACTIVE INGREDIENT

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

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

  • NURSING MOTHERS

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

  • 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.

  • 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
    agedose
    adults and children
    12 years and over    		2 teaspoons
    every 4 hours
    children under 12 yearsdo not use
  • 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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Safetussin DM 
    NON-DROWSY
    COUGH & CHEST CONGESTION

    Safe for adults with

    High Blood Pressure
    Diabetes

    Controls Cough
    Loosens Mucus
    Relieves Chest Congestion

    Sugar & Alcohol Free

    4 FL. OZ (118 ml.)

    Safetussin DM

    TOS + CONGESTION EN EL PECHO

    Dextromethorphan HBr / Antitusivo
    Guaifenesin / Expectorante

    SEGURO para adultos con

    Presión alta
    Diabetes

    Controla la tos
    Afloja la mucosidad
    Alivia la congestión en el pecho

    SIN AZÚCAR Y SIN ALCOHOL

    4 FL. OZ (118 ml.)

    NON-DROWSY
    COUGH + CHEST CONGESTION
    Safetussin contains:
    No decongestants
    No acetaminophen
    No sugar
    No alcohol
    No sorbitol
    No fructose
    No gluten
    No dyes

    Pharmacist Recommended
    Always read and follow label directions. Ask a doctor if you have individual health questions.

    Questions? Comments?
    Call 1-800-824-4894

    ©2020 Kramer Laboratories, Inc.
    Bridgewater, NJ 08807

    K0820

    carton

    Safetussin® DM 
    NON-DROWSY
    COUGH & CHEST CONGESTION
    Dextromethorphan HBr / Cough Suppressant
    Guaifenesin / Expectorant

    Safe for adults with

    High Blood Pressure
    Diabetes

    Controls Cough
    Loosens Mucus
    Relieves Chest Congestion

    4 FL. OZ. (118 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.

    K0820

    Questions? Comments? Call 1-800-824-4894
    ©2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

    label
  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN  DM
    dextromethorpan guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Menthol (UNII: L7T10EIP3A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-111-331 in 1 CARTON02/10/2017
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/29/2010
    Labeler - Kramer Laboratories (122720675)
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