Label: SCOT-TUSSIN DIABETES COUGH FORMULA WITH DM- dextromethorphan hydrobromide 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 January 21, 2013

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    (in each 5 mL. tsp. teaspoon)

    Dextromethorphan HBr. USP 10mg 

  • Purpose

    Cough Suppressant

  • Uses

    • Temporarily quiets and calms a dry cough due to minor throat and bronchial irritation.
  • Warnings

    Do not use

    • more than the recommended dosage.
    • If drowsiness occurs, do not drive or operate machinery.
    • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacists before taking this product.

    Ask a doctor before use is you have

    • a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
    • difficulty in urination due to enlargement of the prostate gland.
    • Glaucoma.
    • Thyroid disease.
    • a chough that occurs with too much phlegm (mucus).

    Stop use and ask a doctor if

    • Cough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    Do Not Use.

    Keep out of reach of children.

    In case of accidental overdose get medical help or contact a poison control center right away.

  • Directions

    • Follow Dosage Chart.
    • Do not take more than 6 doses in any 24 hour period.
    • This product is not intended for use in children under 12 years of age.
    agedose
    Adults and children
    over 12 years old    		2 teaspoons
    (2 tsp. 10 ml)
    every 4 hours
    Children Under
    12 years old    		DO NOT USE
  • Other Information

    • Store at 20º – 25º C (68º – 77º F).
    • Do not refrigerate.
    • Dosage cup provided.
  • Inactive Ingredients

    Ammonium Glycyrrhizate, Citric Acid, Clear Cherry-Strawberry Flavor, Glycerin, Hydroxyethylcellulose, Menthol, Methyl Paraben, Potassium Benzoate, Propyl Paraben, Propylene Glycol, Purified Water.

  • Principal Display Panel

    NDC 0372-0043-04
    SCOT-TUSSIN
    DIABETES
    COUGH SUPPRESASANT Formula with DM

    4 FL OZ (118 ml)

    NDC 0372-0043-04 SCOT-TUSSIN DIABETES COUGH SUPPRESASANT Formula with DM 4 FL OZ (118 ml)

  • INGREDIENTS AND APPEARANCE
    SCOT-TUSSIN DIABETES COUGH FORMULA WITH DM 
    dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0372-0043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0372-0043-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/18/1998
    Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918)
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