Label: GUAIFENESIN solution

  • NDC Code(s): 60687-852-17, 60687-852-40, 60687-852-46, 60687-863-42, view more
    60687-863-48, 60687-863-56, 60687-874-16, 60687-874-44, 60687-874-50
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 17, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Expectorant
    SUGAR FREE / ALCOHOL FREE

  • Active ingredient

    • (in each 5 mL Cup)      Guaifenesin 100 mg
    • (in each 10 mL Cup)      Guaifenesin 200 mg
    • (in each 15 mL Cup)      Guaifenesin 300 mg
  • Purpose

    Expectorant

  • 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 .

  • Directions

    Follow dosage below or use as directed by a physician.

    • do not take more than 6 doses in any 24-hour period.

    Age (yr)

    Dose (ml)

    adults and children 12 years and over

    10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours

    children 6 years to under 12 years

    5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours

    children 2 years to under 6 years

    2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours

    children under 2 years

    consult a physician

    Other Information

    • Each 5 ml contains: sodium 4 mg.
    • Each 10 ml contains: sodium 8 mg.
    • Each 15 ml contains: sodium 12 mg.
    • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
    • DO NOT USE IF SEAL IS BROKEN.
    • Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:
      5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17
      10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56
      15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16
  • 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.

  • Questions or comments?

    Call 1-800-845-8210

  • Generic 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).

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    R0624

  • Package/Label Principal Display Panel – 100 mg per 5 mL – Label

    100 mg per 5 mL Guaifenesin Oral Solution Label

    Case NDC 60687- 852-17/Cup NDC 60687- 852-40

    Guaifenesin
    Oral Solution USP
    Expectorant

    100 mg per 5 ml

    SUGAR FREE / ALCOHOL FREE
    Raspberry Flavor

    Usual Dosage: See attached Drug Facts.

    Store at 20° to 25°C (68° to 77°F) [See USP]
    Protect from light.

    FOR INSTITUTIONAL USE ONLY

    T0744C050624                 R0624

  • Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid

    100 mg per 5 mL Guaifenesin Oral Solution Cup Lid

    NDC 60687- 852-40

    Guaifenesin
    Oral Solution, USP
    Expectorant

    100 mg per 5 ml

    Sugar Free/Alcohol Free
    Delivers 5 mL

    PROTECT FROM LIGHT.

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0744C050624

  • Package/Label Principal Display Panel – 200 mg per 10 mL – Label

    200 mg per 5 mL Guaifenesin Oral Solution Label

    Case NDC 60687- 863-56/Cup NDC 60687- 863-42

    Guaifenesin
    Oral Solution USP
    Expectorant

    200 mg per 10 ml

    Sodium Content: 8 mg/10 ml
    SUGAR FREE / ALCOHOL FREE
    Raspberry Flavor

    Usual Dosage: See attached Drug Facts.

    Store at 20° to 25°C (68° to 77°F) [See USP]
    Protect from light.

    FOR INSTITUTIONAL USE ONLY

    T0744C100624                 R0624

  • Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid

    200 mg per 5 mL Guaifenesin Oral Solution Cup Lid

    NDC 60687- 863-42

    Guaifenesin
    Oral Solution, USP
    Expectorant

    200 mg per 10 ml

    Sodium Content: 8 mg/10 ml
    Sugar Free/Alcohol Free
    Delivers 10 mL

    PROTECT FROM LIGHT.

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0744C100624

  • Package/Label Principal Display Panel – 300 mg per 15 mL – Label

    300 mg per 5 mL Guaifenesin Oral Solution Label

    Case NDC 60687- 874-16/Cup NDC 60687- 874-44

    Guaifenesin
    Oral Solution USP
    Expectorant

    300 mg per 15 ml

    Sodium Content: 12 mg/15 ml
    SUGAR FREE / ALCOHOL FREE
    Raspberry Flavor

    Usual Dosage: See attached Drug Facts.

    Store at 20° to 25°C (68° to 77°F) [See USP]
    Protect from light.

    FOR INSTITUTIONAL USE ONLY

    T0744C150624                 R0624

  • Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid

    300 mg per 5 mL Guaifenesin Oral Solution Cup Lid

    NDC 60687- 874-44

    Guaifenesin
    Oral Solution, USP
    Expectorant

    300 mg per 15 ml

    Sodium Content: 12 mg/15 ml
    Sugar Free/Alcohol Free
    Delivers 15 mL

    PROTECT FROM LIGHT.

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0744C150624

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-852
    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:60687-852-1710 in 1 CASE10/20/2024
    1NDC:60687-852-4610 in 1 TRAY
    1NDC:60687-852-405 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 DrugM01210/20/2024
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-863
    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:60687-863-5610 in 1 CASE10/20/2024
    1NDC:60687-863-4810 in 1 TRAY
    1NDC:60687-863-4210 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 DrugM01210/20/2024
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-874
    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:60687-874-1610 in 1 CASE10/20/2024
    1NDC:60687-874-5010 in 1 TRAY
    1NDC:60687-874-4415 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 DrugM01210/20/2024
    Labeler - American Health Packaging (929561009)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!