Label: EMETROL POWDER NON-DROWSY- sodium citrate dihydrate powder, for solution

  • NDC Code(s): 65197-203-09
  • 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 December 18, 2023

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  • Active ingredients (in each packet)

     
    Sodium citrate dihydrate USP 460 mg
  • Purpose

    Upset stomach reliever

  • Uses

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

  • Warnings

    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 4 packets 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.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ▪
    Adults: 1-2 packets 3 to 4 times a day.
    ▪
    Children: Consult a doctor for appropriate dosage.
    ▪
    Dosage may be repeated after 15 minutes, not to exceed 4 packets in a 24-hour period unless advised by a doctor.
    ▪
    Dissolve contents of one (1) packet in 4 oz. of room temperature water before consumption. Stir again if needed
    ▪
    Read all package directions and warnings before use and use only as directed.
  • Other information

    ▪
    Each table contains: Sodium 110 mg/8 g
    ▪
    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.
  • Inactive ingredients

    Citric acid anhydrous, natural & artificial lemon flavor, silica, sucralose, sucrose.

  • 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

    PHARMACIST RECOMMENDED

    NDC# 65197-203-09

    New

    Non-Drowsy

    Emetrol POWDER

    Rapid Nausea Relief

    •
    Treats the source of Nausea*
    •
    Dissolve Faster in your Stomach
    •
    Great Tasting Lemon Flavor
    •
    Specially Formulated for Adults

    *Due to overindulgence in food and drink

    FSA/HAS Eligible

    lemon flavor

    6 PACKAETS

    Emetrol non-drowsy rapid Nausea Relief 6 packets lemon flavor

  • INGREDIENTS AND APPEARANCE
    EMETROL POWDER  NON-DROWSY
    sodium citrate dihydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID460 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    LEMON (UNII: 24RS0A988O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeSize
    FlavorLEMONImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-203-096 in 1 CARTON; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other12/01/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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