Fexofenadine HCl Tablets USP, 180 mg (Gel Caps)

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Granules India Limited

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Fexofenadine HCl Tablets USP, 180 mg (Gel Caps)

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-623
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIA (UNII: 5138Q19F1X)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	gray (White band in the middle)	Score	no score
Shape	OVAL (capsule shaped tablet)	Size	20mm
Flavor		Imprint Code	G18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-623-97	40000 in 1 DRUM	11/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/27/2023

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-623)

Revised: 12/2023

Document Id: 0bbdb9cb-030c-2ac8-e063-6294a90a8d9a

53409-9

Set id: 0adf9bea-5858-8639-e063-6394a90aa5a1

Version: 2

Effective Time: 20231205