LEVOCETIRIZINE DIHYDROCHLORIDE: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Levocetirizine dihydrochloride tablets, USP are white to off white, film-coated, biconvex, oval-shaped, scored, debossed with ‘M 17′ on one side and contain 5 mg levocetirizine dihydrochloride USP.

This tablet is having functional scoring.

They are supplied in unit of use HDPE bottles.

30 Tablets (NDC 68788-7189-3)

60 Tablets (NDC 68788-7189-6)

90 Tablets (NDC 68788-7189-9)

100 Tablets (NDC 68788-7189-1)

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Somnolence
Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride.

Concomitant Use of Alcohol and other Central Nervous System Depressants
Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur.

Dosing of Levocetirizine Dihydrochloride
Do not exceed the recommended daily dose in adults and adolescents 12 years of age and older of 5 mg once daily in the evening. In children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening. Advise patients to not ingest more than the recommended dose of levocetirizine dihydrochloride because of the increased risk of somnolence at higher doses.

Manufactured for :
Macleods Pharma USA, Inc.
Plainsboro, NJ 08536

Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA

Revised: 04/2019
PM02114009

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only
NDC 68788-7189
Levocetirizine Dihydrochloride tablets, USP 5 mg

Levocetirizine Dihydrochloride Tablets 5mg
(click image for full-size original)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7189(NDC:33342-200)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape OVAL (biconvex) Size 8mm
Flavor Imprint Code ML17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7189-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7189-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7189-9 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7189-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205564 07/17/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7189)

Revised: 06/2020 Preferred Pharmaceuticals Inc.

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