Label: DEXTROMETHORPHAN HBR AND GUAIFENESIN solution

  • 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 March 8, 2022

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  • Active ingredient

    Each 5 mL (1 teaspoonful) contains:

    Dextromethorphan HBr ................................10 mg

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

  • Inactive ingredients

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

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

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

    Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    •
    a cough that occur with too much phlegm (mucus)
    •
    a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    •
    a 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.

    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

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

    Age

    Dose

    Adults & children 12 years & over

    10 mL (2 teaspoonfuls)

    Children 6 years to under 12 years

    5 mL (1 teaspoonful)

    Children 2 years to under 6 years

    2.5 mL (1/2 teaspoonful)

    Children under 2 years

    Ask a doctor

    How Supplied: Dextromethorphan HBr and 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 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.062:01 4/13

    MG #29851

  • Package/Label Principal Display Panel

    Lid-10 mL

    Delivers 10 mL

    NDC 50383-062-10

    DEXTROMETHORPHAN HBr & GUAIFENESIN ORAL SOLUTION

    20 mg/200 mg per 10 mL

    Sugar Free/Alcohol Free

    COUGH SUPPRESSANT/EXPECTORANT

    SEE INSERT

    FOR INSTITUTIONAL USE ONLY

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 062:01 4/13

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR AND GUAIFENESIN 
    dextromethorphan hbr and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-062
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    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:50383-062-064 in 1 CASE03/07/2012
    1NDC:50383-062-0510 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:50383-062-0710 in 1 CASE03/07/2012
    210 in 1 TRAY
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:50383-062-114 in 1 CASE03/07/2012
    3NDC:50383-062-1010 in 1 TRAY
    310 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:50383-062-1210 in 1 CASE03/07/2012
    410 in 1 TRAY
    410 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 Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696873MANUFACTURE(50383-062) , PACK(50383-062)
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