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Name:Nauzene
Manufacturer:Alva-amco Pharmacal Companies, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NAUZENE  - dextrose, fructose and trisodium citrate dihydrate tablet, chewable 
Alva-Amco Pharmacal Companies, Inc.

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.

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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 Chewables PDP


NAUZENE 
glucose, fructose, sodium citrate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-142
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextrose (Dextrose) Dextrose 968 mg
Fructose (Fructose) Fructose 175 mg
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) TRISODIUM CITRATE DIHYDRATE 230 mg
Inactive Ingredients
Ingredient Name Strength
Aspartame  
FD&C Red No. 40  
Magnesium stearate  
Maltodextrin  
Silicon dioxide  
Stearic acid  
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor CHERRY (Wild Cherry Flavor) Imprint Code ALVA
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52389-142-40 4 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (52389-142-40)
2 NDC:52389-142-50 5 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, CHEWABLE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (52389-142-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part357 07/08/2000

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010 Alva-Amco Pharmacal Companies, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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