Label: GUAIFENESIN liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 10, 2024

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  • Active ingredient (in each 5 mL teaspoonful)

    Guaifenesin 100 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.

    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

    • do not take more than 6 doses in any 24-hour period
       Age   Dose
       Adults and Children 12 years and over 2-4 Teaspoonfuls every 4 hours
       Children 6 years to under 12 years 1-2 Teaspoonfuls every 4 hours
       Children 2 years to under 6 years 1/2-1 Teaspoonful every 4 hours
       Under 2 years Ask a doctor

    Drug Facts(continued)

  • Other information

    • store at 20°-25°C (68°-77°F)
    • Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
    • sodium content 3 mg/5 mL
  • Inactive ingredients

    Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

  • Questions?

    You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

    Manufactured for:
    Oncor Pharmaceuticals
    8815 Center Park Dr. Suite 430
    Columbia, Maryland 21045


    Rev. 05/24

  • PRINCIPAL DISPLAY PANEL

    NDC 83720-503-16

    ONCOR PHARMACEUTICALS

    Guaifenesin

    Oral Solution USP

    100 mg/5 mL

    Expectorant

    Relieves Chest Congestion

    Sugar Free • Alcohol Free

    Cherry Flavor

    16 fl. oz. - 473 mL

    Label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-503
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM (UNII: 9NEZ333N27)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83720-503-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/10/2024
    Labeler - Oncor Pharmaceuticals (119032580)
    Registrant - Oncor Pharmaceuticals (119032580)
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