GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]

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GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-0809-04, 0121-0809-08, 0121-4809-05, 0121-4809-10
Set ID 990eef79-5380-48c6-8b8f-d4814e0fd293
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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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