FDA.reportPublic FDA data

Contrast Allergy PreMed Pack

Manufacturer
Shertech Laboratories, LLC
Effective date
2018-03-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:00:59

Label at a glance#

ProductContrast Allergy PreMed Pack
Active ingredientPREDNISONE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 FrontMain BackMain BackSlide FrontSlide FrontSlide BackSlide Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16129-101-012024-01-04C16284748780-19d75b9d1-195c-f424-e053-dadaa90a57ceContrast Allergy PreMed Pack
16129-101-012020-01-31C16284748780-19d75b9d1-195c-f424-e053-dadaa90a57ceContrast Allergy PreMed Pack

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16129-101-01EA - Each16129-10187c90db3-84b4-4cc4-830d-16e238bc0a5912017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16129-10116129-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PREDNISONEVB0R961HZTACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
21e998d2-bb8a-4282-a11f-d4801d23bc763c675b3b-3bd7-4219-e054-00144ff88e882023-12-27Exact identifier
spl set id: 3c675b3b-3bd7-4219-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.