Label: SCOT-TUSSIN DM SF MAXIMUM STRENGTH COUGH COLD- dextromethorphan hydrobromide chlorpheniramine maleate 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 29, 2013

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients

    (in each 5 mL. tsp. teaspoon)

    *Chlorpheniramine Maleate USP 2mg

    Dextromethorphan HBr. USP 15mg 

  • Purpose

    Antihistamine

    Cough Suppressant

  • Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Quiets and calms a dry cough.
    • Temporarily relieves runny nose and sneezing, itching of the nose and throat, and itchy watery eyes due to upper respiratory symptoms.
  • Warnings

    DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

    Do not use 

    • more than the recommended dosage.
    • if you are 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 pharmacists before taking this product.

    Ask a doctor before use is you have

    • Persistent or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or if cough is accompanied by excessive phlegm (mucus).
    • Difficulty in urination due to enlargement of the prostate gland.
    • Glaucoma.
    • Thyroid disease.

    When using this product

    • May cause drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. If you are taking sedatives or tranquilizers, consult your doctor before taking this medicine. Use caution when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if

    • Chough 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 overdose get medical help or contact a Poison Control Center right away.

  • Directions:

    • Follow Dosage Chart.
    • Do not take more than 4 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 6 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 Glycrrhizate, Citric Acid, Clear Cherry-Strawberry Flavor, Glycerin, Hydroxyethylcellulose, Menthol, Methyl Paraben, Potassium Benzoate, Propyl Paraben, Propylene Glycol, Purified Water.

  • PRINCIPAL DISPLAY PANEL

    NDC 0372-0036-04

    SCOT-TUSSIN

    DM

    Maximum Strength
    COUGH SUPPRESSANT & COLD RELIEF

    4 FL OZ (118 ml)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SCOT-TUSSIN  DM SF MAXIMUM STRENGTH COUGH COLD
    dextromethorphan hydrobromide chlorpheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0372-0036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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
    FlavorSTRAWBERRY, CHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0372-0036-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/28/1983
    Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918)
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