Nauzene Chewables

Nauzene Chewables
SPL v15
SPL
SPL Set ID a60660b2-c5db-45a0-885f-de93e655380d
Route
ORAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (230 mg)
Inactive Ingredients
Aspartame Fd&c Red No. 40 Magnesium Stearate Maltodextrin Silicon Dioxide Stearic Acid Dextrose Fructose Modified Corn Starch (1-octenyl Succinic Anhydride) Hypromelloses Povidone K30 Sucrose Cherry

Identifiers & Packaging

Pill Appearance
Imprint: ALVA Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2000-07-08 Until 2023-02-28

Description

Sodium citrate dihydrate 230 mg

Purpose

Upset stomach reliever/antacid


Medication Information

Purpose

Upset stomach reliever/antacid

Description

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.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50568-5

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

Section 50570-1

Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

Section 51945-4

Section 53413-1

Questions?  1-800-792-2582

Section 53414-9

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

Warnings



Directions
  • 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
  • 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

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.

Ask A Doctor Before Use If You
  • have diabetes because this product contains sugar
  • are on a sodium-restricted diet
  • have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine.

Active Ingredient (in Each Chewable Tablet)

Sodium citrate dihydrate 230 mg


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?  1-800-792-2582

Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever/antacid

Warnings



Directions
  • 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 (Other information)
  • 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 ingredients)

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.

Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have diabetes because this product contains sugar
  • are on a sodium-restricted diet
  • have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Sodium citrate dihydrate 230 mg


Advanced Ingredient Data


Raw Label Data

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