CONTRAST ALLERGY PREMED PACK- prednisone, diphenhydramine 
Shertech Laboratories, LLC

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.

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Contrast Allergy PreMed Pack

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

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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)

Revised: 10/2017
Document Id: 5ae22440-c757-9199-e053-2991aa0acad8
Set id: 3c675b3b-3bd7-4219-e054-00144ff88e88
Version: 3
Effective Time: 20171006
 
Shertech Laboratories, LLC