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

Main Front Main Back Slide Front Slide Back

CONTRAST ALLERGY PREMED PACK
prednisone, diphenhydramine kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:16129-101

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16129-101-01	1 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package	09/13/2016	09/14/2016

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

Part 1 of 2

PREDNISONE
prednisone tablet

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 2 of 2

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/13/2016	09/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/13/2016	09/14/2016

Labeler - Shertech Laboratories, LLC (621117279)

Name	Address	ID/FEI	Business Operations
Establishment
Shertech Laboratories, LLC		621117279	manufacture(16129-101)

Revised: 12/2023

Document Id: 21e998d2-bb8a-4282-a11f-d4801d23bc76

Set id: 3c675b3b-3bd7-4219-e054-00144ff88e88

Version: 5

Effective Time: 20231227

Shertech Laboratories, LLC