Label: ADULT COUGH RELIEF DM- 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 May 26, 2020

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

  • Active ingredient (in each 10 mL)

    Dextromethorphan HBr 30 mg

  • Purpose

    Cough suppressant

  • Uses

    • 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) (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 (1-800-222-1222) right away.

  • Directions

    •  do not take more than 4 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • mL = milliliter
    • this adult productis not intended for use in children under 12 years og age
    • adults and children 12 years and over 10 mL every 6 to 8 hours
    • children under 12 years of age: do not use
  • Other information

    • store between  20-25ºC (68º-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, dextrose, ethyl alcohol, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    Adult Cough Relief DM

    Dextromethorphan HBr 30 mg-Cough Suppressant

    ORIGINAL FLAVOR

    Compare to Robitussin® Lingering Cold Long-Acting Cough active ingredient*

    • For ages 12 & over
    • Alcohol 1.4%
    • Dosing cup included
    • Non-Drowsy

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Lingering Cold Long-Acting Cough.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

    P.O BOX 99, PLEASANTON, CA 94566-0009

    1888-723-392

    www.betterlivingbrandsLLC.com

  • Package Label

    Dextromethorphan HBr 30 mg

    SIGNATURE CARE Adult Cough Relief DM

  • INGREDIENTS AND APPEARANCE
    ADULT COUGH RELIEF DM 
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-383
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-383-041 in 1 BOX06/30/2014
    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 FINALpart34106/30/2014
    Labeler - Safeway, Inc. (009137209)