Drug Information for HydrOXYzine hydrochloride (Caraco Pharmaceutical Laboratories, Ltd.): HOW SUPPLIED

HydrOXYzine hydrochloride tablets, USP contains 10 mg, 25 mg, or 50 mg of hydrOXYzine hydrochloride, USP and are supplied as follows:

10 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘112’ on one side and plain on the other side. NDC 57664-112-83 Bottles of 30 CRC NDC 57664-112-88 Bottles of 100 CRC NDC 57664-112-08 Bottles of 100 NCRC NDC 57664-112-13 Bottles of 500 NCRC NDC 57664-112-18 Bottles of 1000 NCRC

25 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with‘113’ on one side and plain on the other side. NDC 57664-113-83 Bottles of 30 CRC NDC 57664-113-88 Bottles of 100 CRC NDC 57664-113-08 Bottles of 100 NCRC NDC 57664-113-13 Bottles of 500 NCRC NDC 57664-113-18 Bottles of 1000 NCRC

50 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘114’ on one side and plain on the other. NDC 57664-114-83 Bottles of 30 CRC NDC 57664-114-88 Bottles of 100 CRC NDC 57664-114-08 Bottles of 100 NCRC NDC 57664-114-13 Bottles of 500 NCRC NDC 57664-114-18 Bottles of 1000 NCRC

Dispense in a tight container as defined in the USP. Store at 20 - 25°C (68 - 77°F). (See USP Controlled Room Temperature).

Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202

Manufactured by: Sun Pharmaceutical Industries, Inc. Cranbury, New Jersey 08512

Issued: November 2008

Stock No. 6033T01