Label: GUAIFENESIN- guaifenesin solution

  • NDC Code(s): 50383-063-05, 50383-063-06, 50383-063-07, 50383-063-10, view more
    50383-063-11, 50383-063-12, 50383-063-15, 50383-063-17, 50383-063-18
  • Packager: Hi-Tech Pharmacal Co., Inc.
  • 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 03/13

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

  • Active ingredient

    Each 5 mL (1 teaspoonful) contains:

    Guaifenesin ................................................ 100 mg

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  • Inactive ingredients

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

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  • Purpose

    Expectorant

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  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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  • Warnings

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic 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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • you are hypersensitive to any of the ingredients

    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.

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

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  • Directions

    Follow dosage below or use as directed by a physician.

    • do not take more than 6 doses in any 24-hour period
    age dose
    adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
    children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
    children 2 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
    children under 2 years of age ask a doctor

    How Supplied:

    Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

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  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

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  • Questions or comments?

    Call 1-800-262-9010.


    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701


    Rev.063:00 10/10

    MG #29850

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  • Package/Label Principal Display Panel

    Lid_063_15 mL

    Delivers 15 mL

    NDC 50383-063-15

    GUAIFENESIN ORAL SOLUTION

    300 mg/15 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    SEE INSERT

    FOR INSTITUTIONAL USE ONLY

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 063:00 10/10

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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50383-063
    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  
    HYPROMELLOSE 2910 (4000 MPA.S)  
    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:50383-063-06 4 in 1 CASE
    1 NDC:50383-063-05 10 in 1 TRAY
    1 5 mL in 1 CUP, UNIT-DOSE
    2 NDC:50383-063-07 10 in 1 CASE
    2 10 in 1 TRAY
    2 5 mL in 1 CUP, UNIT-DOSE
    3 NDC:50383-063-11 4 in 1 CASE
    3 NDC:50383-063-10 10 in 1 TRAY
    3 10 mL in 1 CUP, UNIT-DOSE
    4 NDC:50383-063-12 10 in 1 CASE
    4 10 in 1 TRAY
    4 10 mL in 1 CUP, UNIT-DOSE
    5 NDC:50383-063-17 4 in 1 CASE
    5 NDC:50383-063-15 10 in 1 TRAY
    5 15 mL in 1 CUP, UNIT-DOSE
    6 NDC:50383-063-18 10 in 1 CASE
    6 10 in 1 TRAY
    6 15 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/07/2012
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-063)
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