Label: ANTI NAUSEA (dextrose(glucose),levulose- fructose,phosphoric acid liquid

  • 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 11, 2023

If you are a consumer or patient please visit this version.

  • Active ingredients (per 5 mL)

    Dextrose (glucose) 1.87 g

    Levulose (fructose) 1.87 g

     
    Phosphoric acid 21.5 mg
  • Purpose

    Upset Stomach Reliever

  • Uses

    For relief of upset stomach associated with nausea
  • Warnings

    This product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI).

    Do not use if you have

    allergic reactions to any of the ingredients in this product

    Ask a doctor before use if you have

    diabetes

    Stop use and ask a doctor if

    symptoms persist, return or get worse

    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. (1-800-222-1222)

  • Directions

    for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
    repeat dose every 15 minutes or until distress subsides
    do not take more than 5 doses in 1 hour without consulting a doctor
    measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products.
    mL= milliliter
     
    age
     
    dose
     
    adults and children 12 years of age and over
     
    15 mL or 30 mL
     
    children 2 to under 12 years of age
     
    5 ml or 10 mL
  • Other information

    store at room temperature away from heat and direct light; keep from freezing
    Do not use if printed seal under cap is broken or missing
  • Inactive ingredients

    FD&C red no. 40, flavors, glycerin, methylparaben, purified water.

  • Questions or Comments?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    NDC 0536-1302-97

    Premier Value®

    Compare to the active ingredients in Emetrol®*

    Anti-Nausea Liquid

    Relief from Nausea Due to Upset Stomach Safe and Effective for Children and Adults

    No Antihistamines
    No Salicylates
    No Caffeine

    Cherry Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by:

    RUGBY® LABORATORIES

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    *This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation., owner of the registered trademark Emetrol®.

  • PACKAGE LABEL

    Nausea Control Cherry Flavor 

  • INGREDIENTS AND APPEARANCE
    ANTI NAUSEA 
    dextrose(glucose),levulose(fructose),phosphoric acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2) DEXTROSE, UNSPECIFIED FORM1.87 g  in 5 mL
    FRUCTOSE (UNII: 6YSS42VSEV) (FRUCTOSE - UNII:6YSS42VSEV) FRUCTOSE1.87 g  in 5 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID21.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorRED (Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1302-971 in 1 CARTON09/09/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other09/09/2020
    Labeler - RUGBY LABORATORIES (079246066)