Label: GUAIFENESIN DM- guaifenesin and dextromethorphan syrup

  • NDC Code(s): 0121-0638-00, 0121-0638-04, 0121-0638-05, 0121-0638-08, view more
    0121-0638-16, 0121-1276-00, 0121-1276-10
  • Packager: Pharmaceutical Associates, Inc.
  • 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 June 14, 2022

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  • PURPOSE

    Non-Narcotic, Alcohol Free
    Expectorant/Cough Suppressant

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Guaifenesin100 mg
    Dextromethorphan Hydrobromide10 mg

    Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 

    Sodium Content: 4 mg/5 mL

  • USES

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • 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, 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.
    • you are hypersensitive to any of the ingredients.

    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.

  • SPL UNCLASSIFIED SECTION

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Follow dosage below or use as directed by a physician.

    • do not take more than 6 doses in any 24-hour period.
    agedose
    adults and children
    12 years and over     		10 mL (2 teaspoonfuls)
    every 4 hours
    children 6 years to
    under 12 years     		5 mL (1 teaspoonful)
    every 4 hours
    children 2 years to
    under 6 years     		2.5 mL (1/2 teaspoonful)
    every 4 hours
    children under 2 yearsask a doctor

  • HOW SUPPLIED

    HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

    NDC 0121-0638-04:  4 fl oz (118 mL) bottle

    NDC 0121-0638-08:  8 fl oz (237 mL) bottle

    NDC 0121-0638-16:  16 fl oz (473 mL) bottle

    NDC 0121­0638-05:  5 mL unit dose cup

    NDC 0121-0638-00:  Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-1276-10:  10 mL unit dose cup

    NDC 0121-1276-00:  Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

  • STORAGE AND HANDLING

    STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light. 

  • MANUFACTURED BY

    Pharmaceutical Associates, Inc.
    Greenville, SC 29605
    www.paipharma.com 

    R11/16

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    Delivers 5 mL
    NDC 0121-0638-05

    GUAIFENESIN SYRUP
    and DEXTROMETHORPHAN

    100 mg/10 mg per 5 mL

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    5 mL unit dose cup label

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 0121-0638-04
    NSN 6505-01-318-1565

    Quality®
    Value

    Guaifenesin-DM

    100 mg/10 mg per 5 mL

    EXPECTORANT/COUGH SUPPRESSANT

    Compare to the
    active ingredients in
    *Robitussin ®-DM

    CONTROLS COUGHS

    LOOSENS AND RELIEVES
    CHEST CONGESTION

    4 fl oz (118 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    118 mL bottle label

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    NDC 0121-0638-08

    Quality®
    Value

    Guaifenesin-DM

    100 mg/10 mg per 5 mL

    EXPECTORANT/COUGH SUPPRESSANT

    Compare to the
    active ingredients in
    *Robitussin ®-DM

    CONTROLS COUGHS

    LOOSENS AND RELIEVES
    CHEST CONGESTION

    8 fl oz (237 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    237 mL bottle label

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0638-16

    Quality®
    Value

    Guaifenesin-DM

    100 mg/10 mg per 5 mL

    EXPECTORANT/COUGH SUPPRESSANT

    Compare to the
    active ingredients in
    *Robitussin ®-DM

    CONTROLS COUGHS

    LOOSENS AND RELIEVES
    CHEST CONGESTION

    16 fl oz (473 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    473 mL bottle label

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    Delivers 10 mL

    NDC 0121-1276-10

    GUAIFENESIN SYRUP

    and DEXTROMETHORPHAN

    200 mg/20 mg per 10 mL

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.

    GREENVILLE, SC 29605

    SEE INSERT

    10 unit dose cup label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0638
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0638-0010 in 1 CASE07/01/1992
    110 in 1 TRAY
    1NDC:0121-0638-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-0638-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1992
    3NDC:0121-0638-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1992
    4NDC:0121-0638-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/1992
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1276
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1276-0010 in 1 CASE07/01/1992
    110 in 1 TRAY
    1NDC:0121-1276-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/1992
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0638, 0121-1276)
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