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 October 5, 2020

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

  • Active ingredient (in each 10 mL)

    Guaifenesin 200 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

    10 mL - 20 mL (2 - 4 teaspoons)

    Children under 12 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 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

    Rev #0514:00 04/19

  • Package/Label Principal Display Panel

    Carton Label

    SUGAR & ALCOHOL FREE!

    Specifically Formulated for Diabetics

    Diabetic Tussin®

    CHEST CONGESTION

    Guaifenesin (Expectorant)

    Thins & Loosens Mucus

    4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN EXPECTORANT 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-514
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CHERRY (UNII: BUC5I9595W)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VANILLA (UNII: Q74T35078H)  
    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:61787-514-041 in 1 BOX02/01/2020
    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 finalpart34102/01/2020
    Labeler - Akorn Consumer Health (117696761)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.117696873MANUFACTURE(61787-514)