CONTRAST ALLERGY PREMED PACK- prednisone, diphenhydramine kit

Contrast Allergy PreMed Pack by

Drug Labeling and Warnings

Contrast Allergy PreMed Pack by is a Prescription medication manufactured, distributed, or labeled by Shertech Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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; Type 1: Convenience Kit of Co-Package	09/13/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		3
Part 2		1

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)