Label: GUAIFENESIN liquid

  • NDC Code(s): 81033-102-05, 81033-102-10, 81033-102-51, 81033-102-52
  • Packager: KESIN PHARMA CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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  • Guaifenesin

    Expectorant
    Sugar Free / Dye Free / Alcohol Free

  • Description

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

  • Inactive Ingredients

    Mixture of Guaifenesin with GRAS material additions including Citric Acid, Grape Flavor Methylparaben, Monoammonium Glycyrrhizate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

  • Uses

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

  • Warnings

    Ask a doctor before us 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
  • ASK DOCTOR

    Stop and ask a doctor if

    • cough lasts mor 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 Dose
     Adults and children 12 years and over 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours
     Children 6 years to under 12 years 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours
     Children 2 to under 6 years of age 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours
     Children under 2 years of age Consult a physician

  • SPL UNCLASSIFIED SECTION

    Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms:

    NDC 81033-102-05 Guaifenesin 100mg/5mL (Unit Dose Cup 5mL)
    NDC 81033-102-10 Guaifenesin 200mg/10mL (Unit Dose Cup 10mL)


    STORAGE
    Keep tightly closed. Store at 15-30°C (59-86°F)

  • QUESTIONS

    QUESTIONS OR COMMENTS
    Call 1-833-537-4679

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    NDC 81033-102-51

    Guaifenesin Oral Solution, USP

    Delivers 100mg per 5mL

    FOR INSTITUTIONAL USE ONLY

    50 X 5 mL Unit Dose Cups

    Store at 59°F to 86°F (15°C to 30°C)

    5 mL cup label

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    NDC 81033-102-52

    Guaifenesin Oral Solution, USP

    Delivers 200mg per 10mL

    FOR INSTITUTIONAL USE ONLY

    50 X 10 mL Unit Dose Cups

    Store at 59°F to 86°F (15°C to 30°C)

    10 mL cup label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-102
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-102-5150 in 1 CARTON11/20/2023
    1NDC:81033-102-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:81033-102-5250 in 1 CARTON11/20/2023
    2NDC:81033-102-1010 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 DrugM01211/20/2023
    Labeler - KESIN PHARMA CORPORATION (117447816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma117447816pack(81033-102) , label(81033-102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wittman Pharma, Inc.830980947manufacture(81033-102)
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