Label: GUAIFENESIN solution

  • Category: HUMAN OTC DRUG LABEL

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 November 15, 2022

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  • Active ingredient

    Each 5 mL (1 teaspoonful) contains:

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

  • Inactive ingredients

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

  • Purpose

    Expectorant

  • Uses

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

  • 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).

  • 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)

  • STORAGE

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

  • Questions or comments?

    Call 1-800-262-9010.


    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev.063:01 4/13

    MG #29850

  • Package/Label Principal Display Panel

    Lid - 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. 063:01 4/13

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-063
    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 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    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:50383-063-064 in 1 CASE03/07/201206/05/2017
    1NDC:50383-063-0510 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:50383-063-0710 in 1 CASE03/07/2012
    210 in 1 TRAY
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:50383-063-114 in 1 CASE03/07/201206/05/2017
    3NDC:50383-063-1010 in 1 TRAY
    310 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:50383-063-1210 in 1 CASE03/07/2012
    410 in 1 TRAY
    410 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    5NDC:50383-063-174 in 1 CASE03/07/201206/05/2017
    5NDC:50383-063-1510 in 1 TRAY
    515 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:50383-063-1810 in 1 CASE03/07/2012
    610 in 1 TRAY
    615 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/07/2012
    Labeler - Akorn (117696873)
    Registrant - Akorn Operating Compnay LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696873MANUFACTURE(50383-063) , PACK(50383-063)
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