Label: GUAIFENESIN SYRUP AND DEXTROMETHORPHAN syrup

  • NDC Code(s): 69339-149-05, 69339-149-19, 69339-150-01, 69339-150-19
  • Packager: Natco Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • PURPOSE

    Non-Narcotic - Alcohol Free

  • DRUG FACTS

    Active Ingredient (in each 5 mL cup)                                                                                                                    Purpose
    Guaifenesin, USP 100mg .............................................................................................................................. Expectorant
    Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant

    Active Ingredient (in each 10 mL cup)                                                                                                                   Purpose
    Guaifenesin, USP 200mg .............................................................................................................................. Expectorant
    Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant

    Inactive Ingredients

    Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.

    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

    Ask a doctor or pharmacist before use if you are taking any other drug

    Stop use and ask a doctor if

    • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.
    • 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 (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    AgeDose
    Adults and children
    12 years and over

    10 mL every 4 hours

    Max dose is 60mL in 24-hours
    Children under 12 years of ageAsk a doctor

  • HOW SUPPLIED

    HOW SUPPLIED: 

    Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

    NDC 69339-149-05 (1) unit dose cup 5mL
    NDC 69339-149-19 100 (10x10) unit dose cups 5mL


    Each 10 mL of Guaifenesin Syrup and Dextromethorphan
    contains Guaifenesin 200mg and Dextromethorphan
    Hydrobromide 20mg and is supplied in the following oral
    dosage forms:

    NDC 69339-150-01 (1) unit dose cup 10mL
    NDC 69339-150-19 100 (10x10) unit dose cups 10mL

  • STORAGE AND HANDLING

    Other Information
    • Store at controlled room temperature 20-25ºC (68-77ºF)
    • Do not refrigerate
    • Keep tightly closed
    • Each 5mL contains sodium 3mg
    • Each 10mL contains sodium 6mg
    • Fruit punch flavor
    • Do not use if lid seal is open or damaged
    • See top of cup for lot number and expiration date

  • SPL UNCLASSIFIED SECTION

    Questions or comments?
    Call 201-786-6500

    Dash Pharmaceuticals LLC
    Upper Saddle River, NJ 07458

    DP-UD-PI-AT-[117893] Rev 08/20

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    Delivers 5 mL
    NDC 69339-149-05

    GUAIFENESIN SYRUP &

    DEXTROMETHORPHAN HBr

    100 mg/10 mg per 5 mL

    For Institutional Use Only

    3 69339 14905 8

    Lot # 111

    Exp: 09/22/2020

    See Insert

    Dash Pharmaceuticals LLC

    Upper Saddle River, NJ 07458

    DASH-

    DOSE

    5mL Cup Label

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    Delivers 10 mL
    NDC 69339-150-01

    GUAIFENESIN SYRUP &

    DEXTROMETHORPHAN HBr

    200 mg/20 mg per 10 mL

    For Institutional Use Only

    3 69339 15001 6

    Lot # 111

    Exp: 09/22/2020

    See Insert

    Dash Pharmaceuticals LLC

    Upper Saddle River, NJ 07458

    DASH-

    DOSE

    10 mL cup label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 
    guaifenesin syrup and dextromethorphan syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69339-149
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69339-149-1910 in 1 CASE10/19/2020
    110 in 1 TRAY
    1NDC:69339-149-055 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 DrugM01210/19/2020
    GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 
    guaifenesin syrup and dextromethorphan syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69339-150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69339-150-1910 in 1 CASE10/19/2020
    110 in 1 TRAY
    1NDC:69339-150-0110 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 DrugM01210/19/2020
    Labeler - Natco Pharma USA LLC (079590418)
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