GaviLyte - C
GaviLyte™-C with Flavor Pack(PEG-3350 (240 g) and Electrolytes for Oral Solution, USP) with flavor pack
a8b15625-ca7c-4d57-9f36-3ac2a6d13665
HUMAN PRESCRIPTION DRUG LABEL
Sep 10, 2025
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
polyethylene glycol-3350 and electrolytes with Flavor Pack
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Gavilyte-C with Flavor Pack (PEG-3350 (240g) and electrolytes for oral solution, USP) with flavor pack
Label
Lemon Flavor Pack
HOW SUPPLIED SECTION
HOW SUPPLIED
GaviLyte- C with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter bottle contains polyethylene glycol-3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution.
GaviLyte- C with flavor pack 4liter: NDC 43386-060-19
Store at 20° to 25°C (68° to 77°F): excursions permitted between 15° to 30°C (59° to 86°F).
KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.
LUPIN and the
are registered trademarks of Lupin Pharmaceuticals, Inc.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873, USA
Manufactured for:
Lupin Pharmaceuticals, Inc.
Naples FL, 34108
SAP Code: 278922
Rev. 11/2024