SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID [KRAMER LABORATORIES]

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SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID [KRAMER LABORATORIES]
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NDC 55505-189-36
Set ID 93512e2b-6072-49d2-849e-0a0af0ec9d44
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredients
    (in each 5mL teaspoon)
    		Purpose
    Dextromethorphan HBr, USP 10mgCough Suppressant
    Guaifenesin, USP 100mgExpectorant
  • 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.

  • PREGNANCY OR BREAST FEEDING

    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 years    		do 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

    SAFE FOR ADULTS WITH
    HIGH BLOOD PRESSURE & DIABETES

    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

    SUGAR & ALCOHOL FREE
    8.0 FL OZ (237mL)


    SEGURO PARA ADULTOS CON
    PRESIÓN ALTA Y DIABETES 

    Safetussin® DM

    NO SOMNOLIENTO
    Tos + Congestión en el Pecho

    Dextromethorphan HBr / Antitusivo
    Guaifenesin / Expectorante

    Seguro para adultos con

    ● Presión Alta
    ● Diabetes

    ✓ Controla la tos
    ✓ Afloja la muscosidad
    ✓ Alivia la congestion en el pecho

    SIN AZÚCAR Y SIN ALCOHOL
    8.0 FL OZ (237mL) 

    SAFE FOR ADULTS WITH
    HIGH BLOOD PRESSURE & DIABETES

    Safetussin® DM 
    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

    K0220 

    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

    8.0 FL OZ (237mL)

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

    K0220

    label
  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN  DM
    dextromethorphan guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-189
    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:55505-189-36237 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 Pharmeceuticals001207208manufacture(55505-189)
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