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Nauzene by Alva-Amco Pharmacal Companies, Inc.

Dosage form: tablet, chewable
Ingredients: Dextrose 968mg, Fructose 175mg, TRISODIUM CITRATE DIHYDRATE 230mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-142

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each chewable tablet)

Dextrose (Glucose) 968 mg........................................Anti-nausea

Levulose (Fructose) 175 mg.......................................Anti-nausea

Sodium citrate dihydrate 230 mg.................................Antacid

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 6 doses 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 6 doses 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.
  • Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredients

Aspartame, FDC Red No. 40 Lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, stearic acid.

Questions?  1-800-792-2582

NAUZENE 
glucose, fructose, sodium citrate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-142
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose (Dextrose) Dextrose968 mg
Fructose (Fructose) Fructose175 mg
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) TRISODIUM CITRATE DIHYDRATE230 mg
Inactive Ingredients
Ingredient NameStrength
Aspartame 
FD&C Red No. 40 
Magnesium stearate 
Maltodextrin 
Silicon dioxide 
Stearic acid 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorCHERRY (Wild Cherry Flavor) Imprint Code ALVA
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-142-404 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
2NDC:52389-142-505 BLISTER PACK (BLISTER PACK) in 1 CARTON
210 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35707/08/2000
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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