Label: NAUZENE- sodium citrate syrup
Contains inactivated NDC Code(s)
NDC Code(s): 52389-172-04
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated May 7, 2010
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- Active ingredients (in each 15-mL tablespoon)
- DO NOT USE
- Ask a doctor before use if you
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Read all package directions and warnings before use and use only as directed.
- Adults: 1 - 2 tablespoons (15 - 30 mL).
- Children: Consult a doctor for appropriate dosage.
- Dosage may be repeated after 30 minutes not to exceed 6 doses in a 24-hour period unless advised by a doctor.
- For maximum effectiveness never dilute Nauzene or drink fluids of any kind immediately before or after taking Nauzene.
- Nauzene Liquid is intended for use by normally healthy persons only.
- Persons under 18 years of age should use only as directed by a doctor.
- Sodium content 193 mg/tablespoon (15 mL).
- Store at room temperature.
- ** Contents sealed: Each bottle of Nauzene Liquid has a tamper evident seal around the cap and a safety seal under the cap. Do not use if either of these seals appears broken. NOTE: Nauzene is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
- Serious side effects associated with the use of this product may be reported to the phone number provided below.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
sodium citrate syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-172 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) TRISODIUM CITRATE DIHYDRATE .921 g in 15 mL Dextrose (UNII: IY9XDZ35W2) (Dextrose - UNII:IY9XDZ35W2) Dextrose 4.35 g in 15 mL Fructose (UNII: 6YSS42VSEV) (Fructose - UNII:6YSS42VSEV) Fructose 4.17 g in 15 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY (flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-172-04 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part357 02/15/2000 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)