Label: NAUZENE - trisodium citrate dihydrate, dextrose and fructose syrup

  • NDC Code(s): 52389-172-04
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/10

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

  • Active ingredients (in each 15-mL tablespoon)

    Dextrose (glucose) 4.35 g...........................anti-nausea

    Levulose (fructose) 4.17 g...........................anti-nausea

    Sodium citrate dihydrate, 0.921 g................antacid

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  • Uses

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

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  • Warnings
  • DO NOT USE

    Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

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  • Ask a doctor before use if you

    • you have diabetes because this product contains sugar
    • are on a sodium-restricted diet.
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any other medications.  Antacids may interact with certain prescription drugs.

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  • WHEN USING

    When using this product do not take more than 6 does in a 24-hour period.

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  • STOP USE

    Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Directions

    • Read all package directions and warnings before use and use only as directed.
    • Adults:  1 - 2 tablespoons (15 - 30 mL).
    • Children:  Consult a doctor for appropriate dosage.
    • Dosage may be repeated after 30 minutes not to exceed 6 doses in a 24-hour period unless advised by a doctor.
    • For maximum effectiveness never dilute Nauzene or drink fluids of any kind immediately before or after taking Nauzene.
    • Nauzene Liquid is intended for use by normally healthy persons only.
    • Persons under 18 years of age should use only as directed by a doctor.
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  • Other information

    • Sodium content 193 mg/tablespoon (15 mL).
    • Store at room temperature.
    • ** Contents sealed:  Each bottle of Nauzene Liquid has a tamper evident seal around the cap and a safety seal under the cap.  Do not use if either of these seals appears broken.  NOTE:  Nauzene is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
    • Serious side effects associated with the use of this product may be reported to the phone number provided below.
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  • Inactive ingredients

    Corn syrup, FDC Red No. 40 lake, flavor, fructose syrup, glycerin, methylparaben, phosphoric acid, purified water.

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  • QUESTIONS

    Questions? 1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    NAUZENE 
    sodium citrate syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-172
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) TRISODIUM CITRATE DIHYDRATE .921 g  in 15 mL
    Dextrose (Dextrose) Dextrose 4.35 g  in 15 mL
    Fructose (Fructose) Fructose 4.17 g  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    corn syrup  
    FD&C Red No. 40  
    High fructose corn syrup  
    Glycerin  
    Methylparaben  
    Phosphoric acid  
    Water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-172-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part357 02/15/2000
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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