Label: DIABETIC TUSSIN EXPECTORANT- 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 December 17, 2019

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  • Active ingredient (in each 5 mL)

    Guaifenesin 100 mg

  • Purpose

    Expectorant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
  • Warnings

    Ask a doctor before use if you have:

    •
    a cough that occurs with too much phlegm (mucus)
    •
    a persistent or chronic cough 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 occurs with fever, rash, or headache that lasts

    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

    •
    take every 4 hours
    •
    do not exceed 6 doses in 24 hours

    adults & children 12 years and over

    10 mL - 20 mL (2 - 4 teaspoonfuls)

    children 6 years to under 12 years

    5 mL - 10 mL (1 - 2 teaspoonfuls)

    children 2 years to under 6 years

    2.5 mL - 5 mL (½ - 1 teaspoonful)

    children under 2 years

    ask a doctor
  • Other information

    •
    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
    •
    store at room temperature 20-25°C (68-77°F).
    •
    keep tightly closed.
  • Inactive ingredients

    Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

  • Questions or comments?

    Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

    Rev #063:05 10/11

  • Package/Label Principal Display Panel

    Image of Carton - 118 mL

    NDC 61787-063-04

    Diabetic Tussin®

    Guaifenesin 100 mg/5 mL

    Expectorant

    Loosens & Relieves Chest Congestion

    Thins & Loosens Mucus

    Liquid

    No Sodium, Sorbitol, Fructose & Dyes

    SUGAR & ALCOHOL FREE!

    SAFE FOR DIABETICS

    4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN EXPECTORANT 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-063
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-063-041 in 1 BOX01/01/1996
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1996
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(61787-063)
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