Label: DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredient (in each 5 mL)

    Guaifenesin 100 mg

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  • Purpose

    Expectorant

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  • Uses

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

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  • 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
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  • 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.
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  • 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.

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  • 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

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  • 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)

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  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN EXPECTORANT 
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61787-063
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ASPARTAME  
    HYPROMELLOSES  
    MENTHOL  
    METHYLPARABEN  
    POTASSIUM SORBATE  
    WATER  
    ANHYDROUS CITRIC ACID  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61787-063-04 1 in 1 BOX
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1996
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(61787-063)
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