Label: CONTRAST ALLERGY PREMED PACK- prednisone, diphenhydramine kit

  • NDC Code(s): 16129-101-01
  • Packager: Shertech Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 13, 2018

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Contrast Allergy PreMed Pack TM consists of an administration card containing three Prednisone 50 mg tablets, USP, and one Diphenhydramine Hydrochloride 50 mg capsule, USP, for oral administration.

  • Contrast Allergy PreMed Pack TM

    NDC 16129-101-01

    double therapy

    Contrast Allergy PreMed Pack TM

    PREDNISONE

    DIPHENHYDRAMINE

    BLISTER PACK CONTAINS:

    3 PREDNISONE, USP, 50 mg Tablets; and

    1 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP, 50 mg

    Rx only

    Main FrontMain BackSlide FrontSlide Back

  • INGREDIENTS AND APPEARANCE
    CONTRAST ALLERGY PREMED PACK 
    prednisone, diphenhydramine kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:16129-101
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16129-101-011 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package09/13/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    PREDNISONE 
    prednisone tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE50 mg  in 50 mg
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Part 2 of 2
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 50 mg
    Product Characteristics
    ColorpinkScorescore with uneven pieces
    ShapeCAPSULESize14mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/13/2016
    Labeler - Shertech Laboratories, LLC (621117279)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shertech Laboratories, LLC621117279manufacture(16129-101)