NAUZENE- sodium citrate tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)
Available from:
Alva-Amco Pharmacal Companies, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Upset stomach reliever/antacid For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink. Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose. - have diabetes because this product contains sugar - are on a sodium-restricted diet - have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine. Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.
Authorization status:
unapproved drug other
Authorization number:
52389-242-10, 52389-242-40, 52389-242-42, 52389-242-50, 52389-242-56

NAUZENE- sodium citrate tablet, chewable

Alva-Amco Pharmacal Companies, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Nauzene Chewables

Active ingredient (in each chewable tablet)

Sodium citrate dihydrate 230 mg

Purpos e

Upset stomach reliever/antacid

Us es

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

food and drink.

Warnings

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 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 24 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 breastfeeding, 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 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? 1-800-792-2582

NAUZENE

sodium citrate tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 9 -242

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K) (ANHYDROUS CITRIC ACID -

UNII:XF417D3PSL)

ANHYDROUS CITRIC

ACID

230 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

DEXTRO SE (UNII: IY9 XDZ35W2)

FRUCTO SE (UNII: 6 YSS42VSEV)

MO DIFIED CO RN STARCH ( 1-O CTENYL SUCCINIC ANHYDRIDE) (UNII: 46 1P5CJN6 T)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SUCRO SE (UNII: C151H8 M554)

CHERRY (UNII: BUC5I9 59 5W)

Product Characteristics

Color

pink

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

CHERRY (Wild Cherry Flavo r)

Imprint Code

ALVA

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:5238 9 -242-40

4 in 1 CARTON

0 7/0 8 /20 0 0

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:5238 9 -242-42

3 in 1 CARTON

0 7/0 6 /20 17

2

14 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:5238 9 -242-50

5 in 1 CARTON

10 /0 1/20 0 6

3

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:5238 9 -242-10

1 in 1 CARTON

0 7/15/20 16

4

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:5238 9 -242-56

4 in 1 CARTON

11/16 /20 19

5

14 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 7/0 8 /20 0 0

Alva-Amco Pharmacal Companies, Inc.

Labeler -

Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 12/2019

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