NAUZENE - sodium citrate syrup 
Alva-Amco Pharmacal Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 15-mL tablespoon)

Dextrose (glucose) 4.35 g...........................anti-nausea

Levulose (fructose) 4.17 g...........................anti-nausea

Sodium citrate dihydrate, 0.921 g................antacid

Uses

For the relief of nausea associated with upset stomach, including that due to overindulgence in food or 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.  Antacids may interact with certain prescription drugs.

When using this product do not take more than 6 does 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

Corn syrup, FDC Red No. 40 lake, flavor, fructose syrup, glycerin, methylparaben, phosphoric acid, purified water.

Questions? 1-800-792-2582

Nauzene Liquid PDP

NAUZENE 
sodium citrate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-172
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) TRISODIUM CITRATE DIHYDRATE.921 g  in 15 mL
Dextrose (UNII: IY9XDZ35W2) (Dextrose - UNII:IY9XDZ35W2) Dextrose4.35 g  in 15 mL
Fructose (UNII: 6YSS42VSEV) (Fructose - UNII:6YSS42VSEV) Fructose4.17 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
corn syrup (UNII: 9G5L16BK6N)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
High fructose corn syrup (UNII: XY6UN3QB6S)  
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Phosphoric acid (UNII: E4GA8884NN)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-172-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35702/15/2000
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 5/2010
Document Id: b35b5e0f-9b2e-40ae-9db7-65f245e40844
Set id: 728376f5-6cab-404e-b519-f6c595291d6f
Version: 2
Effective Time: 20100507
 
Alva-Amco Pharmacal Companies, Inc.