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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 11, 2023

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  • 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)
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