Label: CVS LONG ACTING COUGH- dextromethorphan hbr liquid

  • 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 September 14, 2023

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  • Active ingredient (in each 10 mL)

    Dextromethorphan HBr, USP 30 mg

  • Purpose

    Cough suppressant

  • 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
  • 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

    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor if

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

  • Directions

    •
    do not take more than 4 doses in a 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

    10 mL

    every 6 to 8 hours 

     children under 12 years

     do not use 
  • Other information

    •
    each 10 ml contains: sodium 3 mg
    •
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, disodium edetate, FD&C red 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC# 69842-634-04

    *Compare to the active ingredient in Adult Robitussin® Long-Acting Cough*

    Long-Acting

    Cough

    Dextromethorphan HBr (Cough Suppressant)

    Relieves:

    •
    Cough

    8 Hour Relief

    No Added Alcohol

    Sugar-Free

    For Ages 12 & Over

    4 FL OZ (118mL)

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

    DISTRIBUTED BY

    CVS Cough Long-Acting Dextormethorphan HBr 30 mg
  • INGREDIENTS AND APPEARANCE
    CVS LONG ACTING COUGH 
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-634
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-634-041 in 1 BOX05/02/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/02/2022
    Labeler - CVS PHARMACY, INC (062312574)
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