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Nauzene by Alva-Amco Pharmacal Companies, Inc.

Dosage form: tablet, chewable
Ingredients: TRISODIUM CITRATE DIHYDRATE 230mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-242

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Facts

Active ingredient (in each chewable tablet)

Sodium citrate dihydrate 230 mg

Purpose

Upset stomach reliever

Uses

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

Warnings


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.

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

When using this product, do not take more than 24 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 breastfeeding, 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 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:  54 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.
  • 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, glucose, FDC Red No. 40 Lake, flavor, fructose, magnesium stearate, maltodextrin (corn syrup solids contained), silicon dioxide, stearic acid.

Questions?  1-800-792-2582

NAUZENE 
sodium citrate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-242
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID230 mg
Inactive Ingredients
Ingredient NameStrength
Aspartame 
FD&C Red No. 40 
Magnesium stearate 
Maltodextrin 
Silicon dioxide 
Stearic acid 
DEXTROSE 
FRUCTOSE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorCHERRY (Wild Cherry Flavor) Imprint CodeALVA
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-242-404 BLISTER PACK in 1 CARTON
110 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:52389-242-505 BLISTER PACK in 1 CARTON
210 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/08/2000
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 09/2013
 
Alva-Amco Pharmacal Companies, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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