Label: EMETROL CHEWABLES ORANGE- sodium citrate dihydrate tablet, chewable

  • NDC Code(s): 65197-410-60
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 23, 2023

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  • Active ingredients

    • Sodium citrate dihydrate USP 230 mg
  • Purpose

    Upset stomach reliever

  • Uses

    For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

  • Warnings

    Do not use if you have

    • Hereditary Fructose Intolerance (HFI). This product contains fructose.

    Ask a doctor before use if you 

    • have diabetes because this product contains sugar
    • are on a sodium-restricted diet

    Ask a doctor or pharmacist before use if

    • you are taking any other medications. This product may interact with certain prescription drugs.

    When using this product,

    • do not take more than 24 tablets in a 24-hour period.

    Stop use and ask a doctor if

    • nausea lasts more than two weeks or recurs frequently.

    If pregnant or breast-feeding,

    • ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children

  • Directions

    • Adults: 2-4 tablets.
    • Children: Consult a doctor for appropriate dosage.
    • Chew tablets completely. Do not swallow whole
    • Dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor.
    • Read all package directions and warnings before use and use only as directed.
    • These tablets are intended for use by normally healthy persons only.
    • Persons under 18 years of age should use only as directed by a doctor.
  • Other information

    • Each table contains: Sodium 60mg
    • Store at room temperature
    • Protect product from excessive heat, cold and moisture
    • Note: This product is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
    • Do not use if printed seal under cap is broken or missing.
  • Inactive ingredients

    dextrose, flavor, fructose, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silica, sodium carboxymethylcellulose, sucralose.

  • Questions or Comments?

    1-844-241-5454 or Emetrol.com 

  • Distributed By

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243
    (c) 2023 WellSpring Pharmaceutical Corporation

  • PACKAGE LABEL

    # 1 Pharmacist Recommended

    New

    Non-Drowsy

    Emetrol Chewable Rapid Nausea Relief

    Treats the source of Nausea*

    *Due to overindulgence in food and drink

    Powerful, Soothing Relief

    Orange Flavor

    60 Chewable Tablets

    CT20410B

    Emetrol Chewables Orange

    Side Panels

    Emetrol Chewables Rapid Nausea Relief

    Non-Drowsy

    Treats the source of Nausea*

    Specially Formulated for Adults

    Great-tasting Lemon Chewables

    *Due to overindulgence in food and drink

    Emetrol Chewables relieves stomach discomfort with: 

    No Acetaminophen

    No Aspirin

    No Caffeine

  • INGREDIENTS AND APPEARANCE
    EMETROL CHEWABLES ORANGE 
    sodium citrate dihydrate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-410
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID230 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-410-601 in 1 BOX07/01/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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