Label: GUAIFENESIN DM- guaifenesin and dextromethorphan 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 February 1, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL teaspoonful)    		Purposes
    Guaifenesin 200 mgExpectorant
    Dextromethorphan HBr 10 mgCough 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, chronic bronchitis, 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.

    Directions

    • shake well before using
    • do not take more than 6 doses in any 24-hour period
      agedose
      adults and children 12 years and over10 mL (2 teaspoonsful) every 4 hours
      children 6 to under 12 years of age5 mL (1 teaspoonful) every 4 hours
      children 2 to under 6 years of age2.5 mL (1/2 teaspoonful) every 4 hours
      children under 2 yearsconsult a doctor

    Other information

    • each teaspoonful contains: sodium 4 mg
    • store at 20° - 25°C (68° - 77°F)
    • alcohol/sugar free
    • red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).
  • Inactive ingredients

    Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.

  • Questions or comments?

    Call 1-800-845-8210. You may also report serious side effects to this phone number.

  • PRINCIPAL DISPLAY PANEL - 118 mL Label

    NDC 0121-0809-04

    Quality®
    Value

    Maximum Strength

    Guaifenesin DM

    Cough & Chest
    Congestion

    DEXTROMETHORPHAN HBr (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    ALCOHOL / SUGAR FREE
    Relieves Cough /
    Maximum Strength
    Mucus Relief

    4 fl oz (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Label

    PRINCIPAL DISPLAY PANEL - 5 mL Lid

    Delivers 5 mL
    NDC 0121-4809-05

    MAXIMUM STRENGTH
    GUAIFENESIN DM

    Guaifenesin (Expectorant)
    Dextromethorphan HBr (Cough Suppressant)

    200 mg/10 mg per 5 mL

    Alcohol Free / Sugar Free

    FOR INSTITUTIONAL USE ONLY
    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605
    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 5 mL Lid
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0809
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN10 mg  in 5 mL
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0809-08237 mL in 1 BOTTLE
    2NDC:0121-0809-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/17/2010
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4809
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN10 mg  in 5 mL
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-4809-054 in 1 CASE
    110 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE
    2NDC:0121-4809-104 in 1 CASE
    210 in 1 TRAY
    210 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/17/2010
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.044940096MANUFACTURE
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