SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID [KRAMER LABORATORIES]

SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID [KRAMER LABORATORIES]
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NDC 55505-111-33
Set ID ac9f25a7-03cc-461b-af3e-8c16b7146a22
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class
Product Number
Application Number PART341
  • 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

    DAY TIME
    COUGH RELIEF

    Cough Suppressant / Expectorant

    Specially formulated for adults with

    High Blood Pressure
    Diabetes

    Relieves Cough
    Loosens Mucus

    No Sugar
    No Dyes
    No Gluten
    No Alcohol

    4 FL. OZ (118 ml.)

    Safetussin DM 

    ALIVIA LA TOS
    DURANTE EL DIA


    Antitusivo / Expectorante

    SEGURO para los que padecen de

    Presión alta
    Diabetes

    Alivia la tos
    Descongestiona
    el pecho

    SIN AZÚCAR
    Sin
    Colorantes
    Sin
    Gluten
    Sin Alcohol

    4 FL. OZ (118 ml.)

    NON-DROWSY
    COUGH RELIEF

    TO HELP YOU GET 
    THROUGH THE DAY

    Pharmacist Recommended

    Developed by a pharmacist who recognized the need for simple, safe cough relief for adults afflicted with high blood pressure, diabetes or the common cold.

    Specially-formulated Safetussin® is free of alcohol, sugar, dyes, decongestants and other ingredients that are unnecessary for safe, adult-strength cough treatment. Pure and simple.

    Questions? Comments?
    Call 1-800-824-4894 ● safetussin.com


    ©2019 Kramer Laboratories, Inc.
    Bridgewater, NJ 08807 ● kramerlabs.com

    K0519

    carton

    Safetussin® DM 
    NON-DROWSY
    DAY TIME
    COUGH RELIEF

    COUGH SUPPRESSANT/ EXPECTORANT

    Specially formulated for adults with

    High Blood Pressure
    Diabetes

    Relieves Cough
    Loosens Mucus

    4 FL. OZ. (118 mL)

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

    K0519

    www.kramerlabs.com ● www.safetussin.com
    ©2019 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 finalpart34111/29/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(55505-111)