Label: FIRST AID DIRECT COUGH RELIEF DM- guaifenesin dextromethorphan hbr syrup

  • 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 August 10, 2022

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

  • Active ingredients (each 5mL/1 teaspoon)

    • Dextromethorphan HBr 10mg
    • Guaifenesin 100 mg
  • Purposes

    cough suppressant

    expectorant

  • Uses

    temporarily:

    • relieves coughing due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • Warnings

    Do not use

    this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

    Stop use and ask doctor if

    • cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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 24 hours, or as directed by a doctor.

    • adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours
    • children 6-11 years, measure out and take only 1 teaspoon every 4 hours
    • children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours
    • children under 2 years, consult your doctor
  • Other information

    • do not use if dispenser is torn, cut or opened
    • store at room temperature
    • avoid excessive heat and humidity
  • Inactive ingredients

    citric acid, FD&C red 40, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

  • Questions?

    1-800-327-2704

  • Package Label Principal Display Panel Single Dose Pack

    BEND HERE 

    AND TEAR

    Cough Relief DM

    COUGH SUPPRESSANT EXPECTORANT

    1/3 FL OZ (10 mL)

    (2 Teaspoons)

    pouch

    pouch

  • Package Label Principal Display Panel Box

    Cough Relief DM

    COUGH SUPPRESSANT

    EXPECTORANT

    LIQUID COUGH FORMULA

    • CONTROLS COUGHS
    • LOOSENS and RELIEVES CHEST CONGESTIONS
    • ALCOHOL-FREE
    • NON DROWSY FORMULA

    6-10mL Doses per Box

    box

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT COUGH RELIEF DM 
    guaifenesin dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-121-026 in 1 BOX05/13/2022
    1NDC:42961-121-0110 mL in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/13/2022
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(42961-121)