Label: 7 SELECT MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 17, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

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  • Purposes

    Cough suppressant

    Expectorant

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  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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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 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.

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  • 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
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  • Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

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  • Directions

    shake well before using
    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    mL = milliliter
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

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  • Other information

    each 20 mL contains: sodium 7 mg
    store at room temperature. Do not refrigerate.
    Alcohol-free
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  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C Red No. 40, flavor, menthol, microcrystalline cellulose, povidone, propylene glycol, purified water, potassium citrate, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

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  • Questions or comments?

    1-844-428-2538

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  • Package/Label Principal Display Panel

    Compare to Robitussin® Cough + Chest CONGESTION DM the active ingredients*

    NDC# 10202-740-04

    Non-Drowsy

    Maximum Strength

    Cough + Chest Congestion DM

    Dextromethorphan HBr

    Cough Suppressant

    Guaifenesin

    Expectorant

    Relieves Chest Congestion Controls cough and mucus

    QUALITY GUARANTEED

    For Ages 12 & Over

    4 FL OZ (118 mL)

    DISTRIBUTED BY 7-ELEVEN, INC.

    IRVING, TX 75063

    WWW.7-ELEVEN.COM

    SATISFACTION GUARANTEED 1-800-255-0711

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® Cough + Congestion DM.

    7-Eleven Max Str Cough and Chest Congestion DM
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  • INGREDIENTS AND APPEARANCE
    7 SELECT  MAXIMUM STRENGTH
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-740
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor FRUIT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10202-740-04 1 in 1 CARTON 03/25/2019
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/25/2019
    Labeler - 7-ELEVEN (007347602)
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