GUAIFENESIN LIQUID [METHOD PHARMACEUTICALS, LLC]

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GUAIFENESIN LIQUID [METHOD PHARMACEUTICALS, LLC]
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NDC 58657-509-16
Set ID 312ce620-4841-7488-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Method Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART341
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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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