PROMETHAZINE HYDROCHLORIDE tablet

Promethazine hydrochloride by

Drug Labeling and Warnings

Promethazine hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-588-53

MFG: 68382-041-10

Promethazine Hydrochloride 25MG

10 tablets

Rx Only

Lot#: NW58820001

Exp. Date: 05/2015

Each tablet contains: Promethazine hydrochloride, USP....25mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg by: Cadila Healthcare Ltd. India

Distributed by Zydus Pharmaceuticals USA, Inc Pennington, NJ 08534 Lot# MN5816

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-588(NDC:68382-041)
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)	PROMETHAZINE HYDROCHLORIDE	25 mg  in 30

Product Characteristics
Color	white	Score	4 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	ZC02
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-588-53	10 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040596	05/19/2014

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-588)