Label: WALGREEN COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide and guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant
  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    •
    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 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 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)

    When using this product do not use more than directed

    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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    do not use dosing cup with other products
    •
    dose as follows or as directed by a doctor
    •
    adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    each 20 mL contains: sodium 8 mg
    •
    store at room temperature
    •
    do not refrigerate
  • Inactive ingredients

    citric acid, D&C Yellow No. 10, disodium edetate, flavors, FD&C Red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

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  • PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

    NDC 0363-7296-06

    COUGH &
    CHEST
    CONGESTION

    Dextromethorphan HBr (Cough Suppressant)
    Guaifenesin (Expectorant)

    •
    Controls Cough
    •
    Relieves Chest Congestion
    •
    Thins & Loosens Mucus

    Honey & Berry Flavor

    Naturally and Artificially Flavored

    6 fl oz (180 mL)

    For Ages 12+

    Tamper evident: Do not use if printed inner seal under cap is broken or missing.

    Maximum Strength per 4-hour dose

    Distributed by:

    Cough and Chest Congestion
  • INGREDIENTS AND APPEARANCE
    WALGREEN  COUGH AND CHEST CONGESTION
    dextromethorphan hydrobromide and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7296
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 20 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY, BERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7296-06180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/10/2022
    Labeler - WALGREEN COMPANY (008965063)
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