PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet 
DIRECT RX

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PROMETHAZINE HYDROCHLORIDE 25mg

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

STORAGE

PATIENT INFORMATION LEAFLET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMETHAZINE HYDROCHLORIDE 25mg

PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-630(NDC:57664-108)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (WHITE TO OFF WHITE) Score2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 108
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-630-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04086302/18/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-630)

Revised: 2/2016
Document Id: 2c5d4ccc-5d68-0329-e054-00144ff88e88
Set id: 2c5d4ccc-5d67-0329-e054-00144ff88e88
Version: 1
Effective Time: 20160222
 
DIRECT RX