Active Ingredient (In Each Cheable Tablet)
Sodium citrate dihydrate 230 mg
Nauzene Chewables Tablet, Chewable
FDA Label NDC 52389-677
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 Chewables (NDC 52389-677). 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 cheable tablet), purpose, uses, do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if you are, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
For the relief of heartburn, sour stomach, acid indigestion, and upset stomach and accompanying nausea associated with overindulgence in food and drink.
Do Not Use
if you have Hereditary Fructose Intolerance (HFI). This product cnotains fructose.
Ask A Doctor Before Use If You
- have diabetes because this product contains sugar
- are on a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other medications. This product may interact with certain prescription drugs.
When Using This Product,
do not take more than 16 tablets in a 24-hour period.
Stop Use And Ask A Doctor If
nausea lasts more than two weeks or recurs frequently.
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.
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 16 tablets in a 24-hour period unless advised by a doctor.
- Read all package directions and warnings 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 tan 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 darker speckling may occur over time. Note: NAUZENE is not intended as a substitute for a balanced nutritional diet or as an electrolyte replensihment.
- You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients
Acacia, D&C Yellow No. 10 Lake, Dextrose, Flavors (natural and artificial), Fructose, Ginger root, Hydroxypropylcellulose, Magnesium stearate, Malic acid, Maltodextrin, Povidone, Silicon dioxide, Stearic acid, Stevia extract, Sucralose, Sucrose.
Questions?
1-800-792-2582
* Please review the disclaimer below.
