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Contrast Allergy PreMed Pack Prescribing Information

Package insert / product label
Generic name: prednisone, diphenhydramine
Dosage form: kit

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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 FrontMain BackSlide FrontSlide Back

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 3
Part 2 1
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)

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