Label: CONTRAST ALLERGY PREMED PACK- prednisone, diphenhydramine

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

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Drug Label Information

Updated October 6, 2017

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  • 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.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    CONTRAST ALLERGY PREMED PACK 
    prednisone, diphenhydramine kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16129-101
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16129-101-01 1 in 1 BLISTER PACK 09/13/2016
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    PREDNISONE 
    prednisone tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE 50 mg  in 50 mg
    Product Characteristics
    Color white Score score with uneven pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other
    Part 2 of 2
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg  in 50 mg
    Product Characteristics
    Color pink Score score with uneven pieces
    Shape CAPSULE Size 14mm
    Flavor Imprint Code
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/13/2016
    Labeler - Shertech Laboratories, LLC (621117279)
    Establishment
    Name Address ID/FEI Business Operations
    Shertech Laboratories, LLC 621117279 manufacture(16129-101)
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