Label: PROMETHAZINE HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 21, 2014

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  • 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

    Promethazine HCL 25mg 51655-588

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    PROMETHAZINE HYDROCHLORIDE 
    promethazine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-588(NDC:68382-041)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg  in 30 
    Product Characteristics
    ColorwhiteScore4 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code ZC02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-588-5310 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059605/19/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-588)
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