Nauzene

Manufacturer
Alva-Amco Pharmacal Companies, Inc.
Effective date
2010-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:26

Label at a glance#

ProductNauzene
Active ingredientTRISODIUM CITRATE DIHYDRATE, Dextrose, Fructose
Label structure14 sections

Indications and uses

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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients (in each 15-mL tablespoon)

OTC - ACTIVE INGREDIENT SECTION

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

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

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

Uses

OTC - PURPOSE SECTION

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not take more than 6 does 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

  • 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

INFORMATION FOR PATIENTS SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nauzene Liquid PDPNauzene Liquid PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
895045glucose 4.35 GM / fructose 4.17 GM / sodium citrate 0.921 GM in 15 mL Oral SolutionPSN2
895045fructose 278 MG/ML / glucose 290 MG/ML / sodium citrate 61.4 MG/ML Oral SolutionSCD2
895045fructose 4.17 GM / glucose 4.35 GM / sodium citrate 0.921 GM per 15 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072959720049GTIN-13: 0072959720049
EAN-13: 0072959720049
GTIN-12: 072959720049
UPC-A: 072959720049
GTIN storage (14 digits): 00072959720049
NauzeneLiquidPDP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52389-172-042020-01-31C16284748780-19d75b9cf-d79c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-172-04Nauzene118 mL in 1 BOTTLE, PLASTICSYRUP1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-172NAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2Legacy NDC, 1 package rows20100507_728376f5-6cab-404e-b519-f6c595291d6f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DextroseACTIVE INGREDIENTIY9XDZ35W22
FructoseACTIVE INGREDIENT6YSS42VSEV2
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL2
DextroseACTIVE MOIETYIY9XDZ35W22
FructoseACTIVE MOIETY6YSS42VSEV2
corn syrupINACTIVE INGREDIENT9G5L16BK6N2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
High fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6S2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
Phosphoric acidINACTIVE INGREDIENTE4GA8884NN2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-17252389-172-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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 4 · 223 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
High fructose corn syrupHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION, EXTENDED RELEASE / ORAL3000 mgExact identifier — unii candidate
3 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNCREAM / VAGINAL0.56 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNCREAM / TOPICAL13 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNLOTION, AUGMENTED / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
corn syrupCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
High fructose corn syrupHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSOLUTION / ORAL10000 mgExact identifier — unii candidate
3 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
Phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 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
b35b5e0f-9b2e-40ae-9db7-65f245e40844728376f5-6cab-404e-b519-f6c595291d6f2010-05-07WarningsExact identifier
spl id: b35b5e0f-9b2e-40ae-9db7-65f245e40844
spl set id: 728376f5-6cab-404e-b519-f6c595291d6f

Reported adverse events (FAERS/openFDA)#

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