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.

----------

Nauzene Chewables

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 if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

Ask a doctor before use if you

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

Other information

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

NauzeneChewablesPDP

NAUZENE 
sodium citrate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-242
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID230 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorCHERRY (Wild Cherry Flavor) Imprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-242-404 in 1 CARTON07/08/2000
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:52389-242-423 in 1 CARTON07/06/2017
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:52389-242-505 in 1 CARTON10/01/2006
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:52389-242-101 in 1 CARTON07/15/2016
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:52389-242-564 in 1 CARTON11/16/2019
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/08/2000
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 10/2021
Document Id: cf4515a4-01d5-0dc5-e053-2995a90a9638
Set id: a60660b2-c5db-45a0-885f-de93e655380d
Version: 11
Effective Time: 20211026
 
Alva-Amco Pharmacal Companies, Inc.