CLARINEX-D 12 HOUR (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

NDC 78206-120-01
100 Tablets

CLARINEX-D ®
12 HOUR

(desloratadine 2.5 mg/
pseudoephedrine sulfate, USP 120 mg)

EXTENDED RELEASE TABLETS

Rx only

actual size D12

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label
(click image for full-size original)
CLARINEX-D 12 HOUR desloratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
desloratadine (desloratadine) desloratadine 2.5 mg
pseudoephedrine sulfate (pseudoephedrine) pseudoephedrine sulfate 120 mg
Inactive Ingredients
Ingredient Name Strength
hypromellose, unspecified
microcrystalline cellulose
povidone, unspecified
silicon dioxide
magnesium stearate
starch, corn
edetate disodium
anhydrous citric acid
stearic acid
FD&C Blue No. 2
aluminum oxide
Product Characteristics
Color BLUE, WHITE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code D12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-120-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021313 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 06/2021 Organon LLC

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