PROMETHAZINE HYDROCHLORIDE tablet

PROMETHAZINE HYDROCHLORIDE by

Drug Labeling and Warnings

PROMETHAZINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

STORAGE

PATIENT INFORMATION LEAFLET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-630(NDC:57664-108)
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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (WHITE TO OFF WHITE)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	108
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-630-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040863	02/18/2016

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-630)