Quality Choice Tablet, Chewable
FDA Label NDC 83324-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Quality Choice (NDC 83324-300). 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 ingredient (in each chewable tablet), purpose, uses, 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 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.

Otc - Do Not Use

Do not useif 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking 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 ifnausea lasts more than two weeks or recurs frequently.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,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 at 1-800-222-1222.

Directions

  • Adults: 2-4 tablets.
  • Children: Consult a doctor for appropriate dosage.
  • Chew tablets completely. Do not swallow tablet whole.
  • 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 warnings before use and use only as directed.
  • These tablets 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

  • Each tablet contains:sodium 60 mg
  • Store at room temperature.
  • Protect product from excessive heat, cold and moisture.
  • Note:  This product 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?

Inactive Ingredients

dextrose, FDC Red No. 40, flavors, fructose, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silica, sodium carboxymethylcellulose, sucralose.

Questions

1-866-467-2748

Principal Display Panel

Quality Choice®

*Compare to the Active Ingredient in Nauzene® Tablets

NDC# 83324-300-42

Nausea Relief

For upset stomach & nausea

With electrolyte**

Free From:

Gluten, Aspartame

Aspirin and Salicylate

Wild Cherry Flavor

Naturally & Artificially Flavored

42 CHEWABLE TABLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling

Distributed by: CDMA, Inc.

Novi, MI 48375

Questions: 800-935-2362

100% SATISFACTION GUARANTEED

*This product is not manufactured of distributed by ALVA-AMCO Pharmacal Cos., Inc., the distributor of Nauzene® Tablets.

**Sodium citrate dihydrate

* Please review the disclaimer below.