Label: AKIN COUGH FORMULA DM STRAWBERRY BANANA- dextromethorphan hydrobromide, guaifenesin liquid

  • NDC Code(s): 69822-211-04
  • Packager: Southern Sales & Service, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient (in each 5ml tsp.)

    Dextromethorphan HBr USP 10 mg

    Guaifenesin USP 100 mg

    Purpose

    Cough suppressant

    Expectorant

  • Uses

    • temporarily quiets cough associated with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • 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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if

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

    Stop use and ask a doctor if

    • cough lasts for 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 beast-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 hours period

    Adults and children 12 years and over10 ml (2 teaspoonfuls every 4 hours or as directed by doctor)
    Children under 12 yearsdo not use
  • Other information

    • store at room temperature • 15°-30°C (59°-86°F)

    Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

  • Inactive ingredients

    Citric acid, FD&C red #40, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    AKIN COUGH FORMULA DM STRAWBERRY BANANA 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-211
    Route of AdministrationTOPICAL
    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 MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-211-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2023
    Labeler - Southern Sales & Service, Inc. (013114906)
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