Label: EMETROL CHEWABLES- sodium citrate dihydrate tablet, chewable

  • NDC Code(s): 65197-204-42
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 21, 2023

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  • Active ingredients

    •
    Sodium citrate dihydrate USP 230 mg
  • Purpose

    Upset stomach reliever/antacid

  • 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) 2022 WellSpring Pharmaceutical Corporation

  • PACKAGE LABEL

    Pharmacy Recommended

    New

    Non-Drowsy

    Emetrol Chewable Rapid Nausea Relief

    Treats the source of Nausea*

    *Due to overindulgence in food and drink

    Powerful, Soothing Relief

    Lemon Flavor

    42 Chewable Tablets

    Emetrol Chewable Nausea Relief

    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 
    sodium citrate dihydrate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-204
    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, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    LEMON (UNII: 24RS0A988O)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUNDSize16mm
    FlavorLEMONImprint Code CB2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-204-421 in 1 BOX03/15/2022
    142 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/15/2022
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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