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

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GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-0638-00, 0121-0638-04, 0121-0638-05, 0121-0638-08, 0121-0638-16, 0121-1276-00, 0121-1276-10
Set ID ff970fff-d1a3-4322-83b4-34e361431a1c
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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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