Nauzene
FDA Label NDC 52389-172

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alva-amco Pharmacal Companies, Inc. for the product Nauzene (NDC 52389-172). 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 ingredients (in each 15-ml tablespoon), uses, warnings, otc - do not use, ask a doctor before use if you, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 15-Ml Tablespoon)

Dextrose (glucose) 4.35 g...........................anti-nausea

Levulose (fructose) 4.17 g...........................anti-nausea

Sodium citrate dihydrate, 0.921 g................antacid

Uses

For the relief of nausea associated with upset stomach, including that due to overindulgence in food or 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

  • you have diabetes because this product contains sugar
  • are on a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not take more than 6 does 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

  • Read all package directions and warnings before use and use only as directed.
  • Adults:  1 - 2 tablespoons (15 - 30 mL).
  • Children:  Consult a doctor for appropriate dosage.
  • Dosage may be repeated after 30 minutes not to exceed 6 doses in a 24-hour period unless advised by a doctor.
  • For maximum effectiveness never dilute Nauzene or drink fluids of any kind immediately before or after taking Nauzene.
  • Nauzene Liquid is 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 193 mg/tablespoon (15 mL).
  • Store at room temperature.
  • ** Contents sealed:  Each bottle of Nauzene Liquid has a tamper evident seal around the cap and a safety seal under the cap.  Do not use if either of these seals appears broken.  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

Corn syrup, FDC Red No. 40 lake, flavor, fructose syrup, glycerin, methylparaben, phosphoric acid, purified water.

Otc - Questions

Questions? 1-800-792-2582

Package Label.Principal Display Panel

Nauzene Liquid Pdp (Nauzeneliquidpdp)

Nauzene Liquid Pdp (Nauzeneliquidpdp)

* Please review the disclaimer below.