Nauzene Tablet, Chewable
FDA Label NDC 52389-242

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Nauzene (NDC 52389-242). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each chewable tablet), purpose, uses, warnings, otc - do not use, ask a doctor before use if you, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Chewable Tablet)

Sodium citrate dihydrate 230 mg

Uses

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

  • have diabetes because this product contains sugar
  • are on a sodium-restricted diet
  • have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine.

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product, do not take more than 24 tablets 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

  • Adults: 2 - 4 tablets.
  • Children:  Consult a doctor for appropriate dosage.
  • Chew tablets completely.
  • Dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor.
  • Read all package directions and warning before use and use only as directed.
  • Nauzene Chewables are 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:  60 mg/tablet
  • Store at room temperature.
  • **Contents sealed:  Each round pink Nauzene chewable tablet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a foil backing.  Do not use if seal appears broken or if product contents do not match product description. Slight red speckling may occur over time.
  • Note:  Nauzene is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive Ingredients

Aspartame, bitter masking salt, dextrose, FDC Red No. 40 Lake, flavors, food starch-modified, fructose, hypromellose, magnesium stearate, maltodextrin, povidone, silicon dioxide, stearic acid, sucrose.

Otc - Questions

Questions?  1-800-792-2582

* Please review the disclaimer below.