Label: SCOT-TUSSIN EXPECTORANT SF COUGH- 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 January 29, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

  • Active Ingredient: 

    (in each 5 mL. tsp. teaspoon)

    Guaifenesin 100mg

  • Purpose

    Expectorant

  • Uses

    • Helps loosen phlegm (mucus) to make coughs more productive thereby relieving chest congestion.
  • Warnings

    • Do not exceed recommended dosage.
    • *Phenylketonurics: Contains Phenylalanine.

    When using this product

    • Don’t take more than the recommended dosage.

    Ask a doctor before use if you have

    • a Cough that occurs with too much phlegm (mucus).
    • a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

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

  • Directions:

    • Follow Dosage Chart.
    • Do not take more than the six 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

    • each teaspoon contains Phenylalanine 2.5 mg
    • store at 20º – 25º C (68º – 77º F).
    • do not refigerate.
    • dosage cup provided.
  • Inactive Ingredients

    Aspartame* (see warning) Benzoic Acid, Citric Acid, Clear Grape Flavor, Glycerin, Hydroxypropylmethylcellulose, Menthol, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water.

  • PRINCIPAL DISPLAY PANEL

    NDC 0372-0006-04

    SCOT-TUSSIN

    EXPECTORANT

    COUGH

    4 FL OZ (118 ml)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SCOT-TUSSIN EXPECTORANT SF COUGH 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0372-0006
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0372-0006-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/01/1974
    Labeler - SCOT-TUSSIN Pharmacal Co., Inc. (001203918)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!