Label: GUAIFENESIN liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • SPL UNCLASSIFIED SECTION

    NDC 58657-508-16

    Guaifenesin

    Liquid USP

    100 mg/5 Ml

    Expectorant

    Sugar Free • Alcohol Free

    Cherry Flavor

    Loosens and Relieves Chest Congestion

    16 fl. oz. (473 mL)

    Drug Facts

  • Active ingredient (in each 5 mL)

    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

    When using this product

    • Do not use more than directed

    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
      agedose
      adults and children 12 years and over2 to 4 teaspoonfuls every 4 hours
      children 6 years to under 12 years1 to 2 teaspoonfuls every 4 hours
      children 2 to under 6 yars1/2 to 1 teaspoonful every 4 hours
      children under 2 yearsask a doctor

  • Other information

    • store at 20°-25°C (68°-77°F)
    • packaged with tamper evident seal under cap
    • each 5 mL contains: sodium 3 mg
  • Inactive ingredients

    Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

  • Questions or Comments

    1-877-250-3427

    Manufactured For:
    Method Pharmaceuticals, LLC
    Southlake, TX 79092

    LR-205

    Rev-2024

  • HOW SUPPLIED

    Guaifenesin Liquid USP 100 mg/5 mL

    • NDC 72162-2278-2: Bottle of 16 fl. oz. (473 mL) 

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin Liquid 100 mg/5 mL

    Label
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72162-2278(NDC:58657-508)
    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
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CARAMEL (UNII: T9D99G2B1R)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72162-2278-2473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2024
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(72162-2278) , RELABEL(72162-2278)
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