CETIRIZINE HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)

Available from:

Granules India Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

Export only

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET, COATED
GRANULES INDIA LTD
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CETRIZINE HYDROCHLORIDE TABLETS
PRINCIPAL DISPLAY PANEL
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:62207-764
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE -
UNII:YO7261ME24)
CETIRIZ INE
HYDROCHLORIDE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Granules India Ltd
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PRODUCT CHARACTERISTICS
COLOR
white (white to off white)
SCORE
2 pieces
SHAPE
RECTANGLE (rounded off rectangualr)
SIZE
9mm
FLAVOR
IMPRINT CODE
G;4
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:62207-764-
88
100000 in 1 BOX
06/15/2018
1
NDC:62207-764-
30
20000 in 1 POUCH; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
Export only
06/15/2018
LABELER -
Granules India Ltd (915000087)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Granules India Ltd
918609236
manufacture(62207-764)
Revised: 2/2023