FDA Label for Nauzene

View Indications, Usage & Precautions

Nauzene Product Label

The following document was submitted to the FDA by the labeler of this product Alva-amco Pharmacal Companies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Uses



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


Warnings





Otc - Do Not Use



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


Ask A Doctor Before Use If You



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

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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


Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


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.

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.

Inactive Ingredients



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


Otc - Questions



Questions? 1-800-792-2582


Package Label.Principal Display Panel




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