NAUZENE CHEWABLES GINGER HONEY- sodium citrate tablet, chewable

Drug Details [pdf]

Active ingredient (in each cheable tablet)

Sodium citrate dihydrate 230 mg
Purpose

Antacid
Uses

For the relief of heartburn, sour stomach, acid indigestion, and upset stomach and accompanying nausea associated with overindulgence in food and drink.
Warnings
Do not use

if you have Hereditary Fructose Intolerance (HFI). This product cnotains fructose.
Ask a doctor before use if you
- have diabetes because this product contains sugar
- are on a sodium-restricted diet
Ask a doctor or pharmacist before use if you are

taking any other medications. This product may interact with certain prescription drugs.
When using this product,

do not take more than 16 tablets in a 24-hour period.
Stop use and ask a doctor if

nausea lasts more than two weeks or recurs frequently.
If pregnant or breast-feeding,

ask a health professional before use.
Keep out of reach of children.

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

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?

1-800-792-2582
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAUZENE CHEWABLES GINGER HONEY
sodium citrate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-677
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	230 mg

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
POVIDONE K30 (UNII: U725QWY32X)
MALIC ACID (UNII: 817L1N4CKP)
STEVIA LEAF (UNII: 6TC6NN0876)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
SUCROSE (UNII: C151H8M554)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FRUCTOSE (UNII: 6YSS42VSEV)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	16mm
Flavor	GINGER (Ginger-Honey flavor)	Imprint Code	ALVA
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 52389-677-42	3 in 1 CARTON	02/17/2025
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M001	02/17/2025

Labeler - Kobayashi Healthcare International, Inc. (156391729)

Registrant - Kobayashi America Manufacturing, LLC (079852150)

NAUZENE CHEWABLES GINGER HONEY- sodium citrate tablet, chewable

Nauzene Chewables by

Drug Labeling and Warnings

Drug Details [pdf]