Label: SELECTHEALTH TUSSIN DM- 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 August 26, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    (in each 5 mL tsp)    		Purposes
    Dextromethorphan HBr, USP 10 mgCough suppressant
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • 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 you prescription 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 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.

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

    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
    • adults and children 12 years of age and over
      2 teaspoons every 4 hours
    • children under 12 years do not use
  • Other information

    • each teaspoon contains: sodium 7 mg
    • store 20 to 25°C (68 to 77°F)
    • dosage cup provided
  • Inactive Ingredients

    anhydrous citric acid, FD&C red no.40, glycerin, high fructose corn syrup, menthol, natural flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

  • Questions?

    Adverse drug event call (888) 933-3222

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Axcentria Pharmaceuticals, LLC.
    306 Keystone Drive
    Telford, PA 18969 USA

  • PRINCIPAL DISPLAY PANEL - 240 ML Bottle Carton

    *COMPARE TO the active ingredient
    in ROBITUSSIN PEAK COLD

    Tussin
    DM

    HealthSelect®

    Cough & Chest
    Congestion DM

    Dextromethorphan HBr, USP
    Cough Suppressant

    Antitusiv-Dextrometorfano HBr
    Expectorant

    Relieves:

    • Cough
    • Chest Congestion

    NON-DROWSY
    AGES 12+

    NET 8 FL OZ
    (240 ML)
    NDC 49743-3001-1

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SELECTHEALTH TUSSIN DM 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49743-3001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Menthol (UNII: L7T10EIP3A)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49743-3001-1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2011
    Labeler - Axcentria Pharmaceuticals, LLC. (961871501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Axcentria Pharmaceuticals, LLC.961871501MANUFACTURE
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