Nauzene Chewables

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:47

Label at a glance#

ProductNauzene Chewables Ginger Honey
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure15 sections

Indications and uses

For the relief of heartburn, sour stomach, acid indigestion, and upset stomach and accompanying nausea associated with overindulgence in food and drink.

Dosage and administration

Adults: 2-4 tablets. Children: Consult a doctor for appropriate dosage. Chew tablets completely. Dosage may be repeated after 15 minutes, not to exceed 16 tablets in a 24-hour period unless advised by a doctor. Read all package directions and warnings 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 direct...

Label contents#

Full prescribing information#

Active ingredient (in each cheable tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium citrate dihydrate 230 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

For the relief of heartburn, sour stomach, acid indigestion, and upset stomach and accompanying nausea associated with overindulgence in food and drink.

Do not use

OTC - DO NOT USE SECTION

if you have Hereditary Fructose Intolerance (HFI). This product cnotains fructose.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other medications. This product may interact with certain prescription drugs.

When using this product,

OTC - WHEN USING SECTION

do not take more than 16 tablets in a 24-hour period.

Stop use and ask a doctor if

OTC - STOP USE SECTION

nausea lasts more than two weeks or recurs frequently.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: 2-4 tablets.
  • Children: Consult a doctor for appropriate dosage.
  • Chew tablets completely.
  • Dosage may be repeated after 15 minutes, not to exceed 16 tablets in a 24-hour period unless advised by a doctor.
  • Read all package directions and warnings 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

OTHER SAFETY INFORMATION

  • Sodium content: 60 mg/tablet
  • Store at room temperature.
  • **Contents Sealed: Each round tan 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. Slight darker speckling may occur over time. Note: NAUZENE is not intended as a substitute for a balanced nutritional diet or as an electrolyte replensihment.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, D&C Yellow No. 10 Lake, Dextrose, Flavors (natural and artificial), Fructose, Ginger root, Hydroxypropylcellulose, Magnesium stearate, Malic acid, Maltodextrin, Povidone, Silicon dioxide, Stearic acid, Stevia extract, Sucralose, Sucrose.

Questions?

OTC - QUESTIONS SECTION

1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2002800sodium citrate 230 MG Chewable TabletPSN2
2002800sodium citrate 230 MG Chewable TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-677-42Nauzene ChewablesGinger Honey3 in 1 CARTONTABLET, CHEWABLE32
52389-677-42Nauzene ChewablesGinger Honey14 in 1 BLISTER PACKTABLET, CHEWABLE142

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-67752389-677-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
ndc (package): 52389-677-42
ndc (product): 52389-677
ndc11 (package): 52389067742
spl id: 3855cf13-09b3-1dd7-e063-6394a90a19d1
spl set id: 25c9825d-a4e8-4671-e063-6294a90ab46d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.