Label: GUAIFENESIN liquid

  • NDC Code(s): 58657-509-16
  • Packager: Method Pharmaceuticals, LLC
  • 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 December 30, 2021

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  • SPL UNCLASSIFIED SECTION

    NDC 58657-509-16

    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

    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 2 to 4 teaspoonfuls 
      12 years and over every 4 hours 
      children 6 years to 1 to 2 teaspoonfuls 
      under 12 years every 4 hours 
      children 2 years to ½ to 1 teaspoonful 
      under 6 years every 4 hours 
      children under 2 years ask a doctor

    Drug Facts (continued)

  • Other information

    • store at 20°-25°C (68°-77°F)
    • packaged with tamper evident seal under cap
  • Inactive ingredients

    Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

  • Questions or Comments

    1-877-250-3427

    Manufactured For:
    Method Pharmaceuticals, LLC
    Fort Worth, Texas 76118 Rev. 09/16

  • PRINCIPAL DISPLAY PANEL

    NDC 58657- 509- 16
    Guaifenesin
    Liquid USP
    100 mg/ 5 mL
    Expectorant
    16 fl. oz. (473 mL)

    PRINCIPAL DISPLAY PANEL NDC 58657- 509- 16 Guaifenesin Liquid USP 100 mg/ 5 mL Expectorant 16 fl. oz. (473 mL)

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-509
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-509-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/09/2016
    Labeler - Method Pharmaceuticals, LLC (060216698)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(58657-509)
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