NAUZENE- sodium citrate tablet, chewable

Nauzene by

Drug Labeling and Warnings

Nauzene by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Sodium citrate dihydrate 230 mg

Purpose

Upset stomach reliever/antacid

Uses

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

Warnings

DO NOT USE

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

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.
  

ASK DOCTOR/PHARMACIST

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

WHEN USING

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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 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.

QUESTIONS

Questions?  1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAUZENE 
sodium citrate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-242
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE (UNII: IY9XDZ35W2)
FRUCTOSE (UNII: 6YSS42VSEV)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
SUCROSE (UNII: C151H8M554)
CHERRY (UNII: BUC5I9595W)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY (Wild Cherry Flavor)	Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-242-40	4 in 1 CARTON	07/08/2000
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-242-42	3 in 1 CARTON	07/06/2017
2		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 52389-242-50	5 in 1 CARTON	10/01/2006
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 52389-242-10	1 in 1 CARTON	07/15/2016
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 52389-242-56	4 in 1 CARTON	11/16/2019
5		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/08/2000

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)