Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide syrup liquid

  • NDC Code(s): 83720-501-08, 83720-501-16
  • Packager: Oncor Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2025

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  • Active ingredients

    (in each 5 mL teaspoonful)                                    Purpose

    Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant
    Guaifenesin 100 mg.............................................Expectorant

  • Uses

    temporarily Relieves

    - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

    - the intensity of coughing

    - the impulse to cough to help you get to sleep

  • Warnings

    Do not exceed recommended dosage.

  • Do not use this product

    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 2 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

    - persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

    - cough that occurs with too much phlegm (mucus)

  • 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.

  • Directions

    do not exceed recommended dosage.

    adults and children 12 years and over:2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
    children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
    children under 6 years of age:consult a physician

  • Inactive ingredients

    cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

  • Other information

    - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

    - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • Questions?

    You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

  • Principal Display Panel

    Oncor Pharmaceuticals

    NDC 83720-501-16

    Guaifenesin and Dextromethorphan hydrobromide USP

    100 mg/10 mg

    Expectorant
    Cough Suppressant

    Non Drowsy - Alcohol Free

    For Ages 12 & Up

    CHERRY FLAVOR

    NET WT. 16 fl. oz. (473 ml)

    NDC 83720-501-08

    Guaifenesin and Dextromethorphan hydrobromide USP

    100 mg/10 mg

    Expectorant
    Cough Suppressant

    Non Drowsy - Alcohol Free

    For Ages 12 & Up

    CHERRY FLAVOR

    NET WT. 8 OZ. (237 ml)

    Manufactured In USA For :

    Oncor Pharmaceuticals
    6755 Business Pkwy Suite 202
    Elkridge, MD 21075
    United States.
    Rev. 02/25

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin and Dextromethorphan 16ozGuaifenesin and Dextromethorphan 8oz

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide syrup liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-501
    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
    CITRIC ACID (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CHERRY (UNII: BUC5I9595W)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83720-501-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    2NDC:83720-501-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2025
    Labeler - Oncor Pharmaceuticals (119032580)
    Registrant - Oncor Pharmaceuticals (119032580)
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