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  5. Label Information: Nauzene

FDA Label for Nauzene

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 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.