Label: GUAIFENESIN solution

  • NDC Code(s): 0121-0744-04, 0121-0744-08, 0121-0744-16, 0121-1488-00, view more
    0121-1488-10, 0121-1744-00, 0121-1744-05, 0121-2232-00, 0121-2232-15
  • 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

    Expectorant
    SUGAR FREE / ALCOHOL FREE

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Guaifenesin 100 mg

  • Inactive Ingredients

    Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

    Sodium Content: 4 mg/5 mL

  • USES

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • WARNINGS

    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.

  • 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).

  • 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 over10 to 20 mL
    (2 to 4 teaspoonfuls)
    every 4 hours
    children 6 years to under 12 years5 to 10 mL
    (1 to 2 teaspoonfuls)
    every 4 hours
    children 2 to under 6 years of age2.5 to 5 mL
    (½ to 1 teaspoonful)
    every 4 hours
    children under 2 years of ageconsult a physician
  • HOW SUPPLIED

    Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

    NDC 0121-0744-04: 4 fl oz (120 mL) bottle
    NDC 0121-0744-08: 8 fl oz (237 mL) bottle
    NDC 0121-0744-16: 16 fl oz (473 mL) bottle

    NDC 0121-1744-05: 5 mL unit dose cup
    NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-1488-10: 10 mL unit dose cup
    NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-2232-15: 15 mL unit dose cup
    NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

  • STORAGE

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

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0744-16

    Quality ®
    Value

    Guaifenesin Oral Solution USP

    100 mg/5 mL

    EXPECTORANT

    Compare to the
    active ingredient in
    *Robitussin®

    SUGAR FREE/ALCOHOL FREE
    LOOSENS AND RELIEVES
    CHEST CONGESTION

    16 fl oz (473 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    Delivers 5 mL

    NDC 0121-1744-05

    G UAIFENESIN O RAL S OLUTION USP

    100 mg/5 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

    Delivers 10 mL

    NDC 0121-1488-10

    G UAIFENESIN O RAL S OLUTION USP

    200 mg/10 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

  • PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

    Delivers 15 mL

    NDC 0121-2232-15

    G UAIFENESIN O RAL S OLUTION USP

    300 mg/15 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 15 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0744-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    2NDC:0121-0744-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    3NDC:0121-0744-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1744-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-1744-055 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 finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1488-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-1488-1010 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 finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-2232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-2232-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-2232-1515 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 finalpart34109/01/2002
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0744, 0121-1744, 0121-1488, 0121-2232)
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