FDA.reportPublic FDA data

Nauzene

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:59:58

Label at a glance#

ProductNauzene
Active ingredientTRISODIUM CITRATE DIHYDRATE
Label structure15 sections

Indications and uses

For the relief of nausea associated with upset/sour stomach, including that due to 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 24 tablets 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 dire...

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium citrate dihydrate 230 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antacid

Uses

INDICATIONS & USAGE SECTION

For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

OTC - DO NOT USE SECTION

Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains 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
  • have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product, do not take more than 24 tablets in a 24-hour period.

OTC - STOP USE SECTION

Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  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 24 tablets 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

INFORMATION FOR PATIENTS SECTION

  • Sodium content:  60 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. Slight red speckling may occur over time.
  • Note:  Nauzene 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? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aspartame, bitter masking salt, dextrose, FDC Red No. 40 Lake, flavors, food starch-modified, fructose, hypromellose, magnesium stearate, maltodextrin, povidone, silicon dioxide, stearic acid, sucrose.

OTC - QUESTIONS SECTION

Questions?  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 TabletPSN15
2002800sodium citrate 230 MG Chewable TabletSCD15

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-242-10Nauzene1 in 1 CARTONTABLET, CHEWABLE115
52389-242-10Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-40Nauzene4 in 1 CARTONTABLET, CHEWABLE415
52389-242-40Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-42Nauzene14 in 1 BLISTER PACKTABLET, CHEWABLE1415
52389-242-42Nauzene3 in 1 CARTONTABLET, CHEWABLE315
52389-242-50Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-50Nauzene5 in 1 CARTONTABLET, CHEWABLE515
52389-242-56Nauzene14 in 1 BLISTER PACKTABLET, CHEWABLE1415
52389-242-56Nauzene4 in 1 CARTONTABLET, CHEWABLE415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-242NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]15Current NDC, Legacy NDC, 10 package rows20250430_a60660b2-c5db-45a0-885f-de93e655380d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K3
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL3
AspartameINACTIVE INGREDIENTZ0H242BBR13
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W23
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA3
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEV3
hypromellosesINACTIVE INGREDIENT3NXW29V3WO3
Magnesium stearateINACTIVE INGREDIENT70097M6I303
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D3
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6T3
POVIDONEINACTIVE INGREDIENTFZ989GH94E3
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU43
Stearic acidINACTIVE INGREDIENT4ELV7Z65AP3
SUCROSEINACTIVE INGREDIENTC151H8M5543

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-24252389-242-40, 52389-242-42, 52389-242-50, 52389-242-10, 52389-242-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
DEXTROSEIY9XDZ35W2IACT
FRUCTOSE6YSS42VSEVIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
HYPROMELLOSES3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
SUCROSEC151H8M554IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM
CHERRYBUC5I9595WIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 120 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii+route
12 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVTABLET / ORAL64.92 mgExact identifier — unii+route
48 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii+route
12 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVTABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii+route
48 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii+route
12 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SOLUTION / ORAL2625 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSOLUTION / ORAL13872 mgExact identifier — unii+route
48 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSYRUP / ORAL1732.5 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVTABLET / ORAL64.92 mgExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSOLUTION / ORAL13872 mgExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SOLUTION / ORAL2625 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSOLUTION / ORAL13872 mgExact identifier — unii+route
48 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
48 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
48 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
48 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii+route
12 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
48 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SOLUTION / ORAL2625 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
48 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii+route
12 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVTABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii+route
48 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii+route
12 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii+route
12 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSYRUP / ORAL1732.5 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
48 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii+route
12 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
48 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSYRUP / ORAL1732.5 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

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
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
ndc (package): 52389-242-50
ndc (package): 52389-242-40
ndc (package): 52389-242-42
ndc (package): 52389-242-10
ndc (package): 52389-242-56
ndc (product): 52389-242
ndc11 (package): 52389024250
ndc11 (package): 52389024242
ndc11 (package): 52389024256
ndc11 (package): 52389024240
ndc11 (package): 52389024210
spl id: 2d7c94e6-382b-1655-e063-6394a90a712d
spl set id: a60660b2-c5db-45a0-885f-de93e655380d

Reported adverse events (FAERS/openFDA)#

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