Label: DEXTROMETHORPHAN HBR AND GUAIFENESIN- dextromethorphan hydrobromide and guaifenesin solution

  • NDC Code(s): 50383-062-05, 50383-062-06, 50383-062-07, 50383-062-10, view more
    50383-062-11, 50383-062-12
  • 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:

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

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

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  • Inactive ingredients

    Acesulfame potassium, 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

    Cough Suppressant

    Expectorant

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  • Uses

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

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  • 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.

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  • QUESTIONS OR COMMENTS?

    Call 1-800-262-9010.


    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701


    Rev.062:00 10/10

    MG #29851

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  • Package/Label Principal Display Panel

    Lid_062_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. 062:00 10/10

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  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR AND GUAIFENESIN 
    dextromethorphan hbr and guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50383-062
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    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:50383-062-06 4 in 1 CASE
    1 NDC:50383-062-05 10 in 1 TRAY
    1 5 mL in 1 CUP, UNIT-DOSE
    2 NDC:50383-062-07 10 in 1 CASE
    2 10 in 1 TRAY
    2 5 mL in 1 CUP, UNIT-DOSE
    3 NDC:50383-062-11 4 in 1 CASE
    3 NDC:50383-062-10 10 in 1 TRAY
    3 10 mL in 1 CUP, UNIT-DOSE
    4 NDC:50383-062-12 10 in 1 CASE
    4 10 in 1 TRAY
    4 10 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(50383-062)
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