FEXOFENADINE HYDROCHLORIDE tablet

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

kidney disease. Your doctor should determine if you need a different dose.

When using this product

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and over: take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
• children under 12 years of age: do not use
• adults 65 years of age and older: ask a doctor
• consumers with kidney disease: ask a doctor

Other information

• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
• store between 20º and 25ºC (68º and 77ºF)
• protect from excessive moisture

Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, titanium dioxide.

Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Manufactured By:
Granules India Limited
Hyderabad-500 081, India

MADE IN INDIA

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

PRINCIPAL DISPLAY PANEL 180 mg - 24s Container Label

NDC: 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY
RELIEF 24HR

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in

Allegra ® Allergy 24 HOUR

PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton

NDC: 62207-623-41
NON-DROWSY

Fexofenadine HCl
Tablets, USP

180 mg

Allergy

Antihistamine
INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

24 GELCAPS
Gel Coated Tablets

*Compare to the active ingredient in Allegra ®

Allergy 24 HOUR

PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton

NDC: 62207-623-71
NON-DROWSY

Fexofenadine HCl Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

70 (7x10) GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR

PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil

NDC: 62207-623-71
Fexofenadine HCl
Tablet USP, 180 mg
Allergy

Antihistamine (GELCAP)
Mfg. by: Granules India Limited
Made in India

M.L.No.: 37/RR/AP/2003/F/R 24 HR
Push tablet through foil

LOT#
EXP. DATE:

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-623
Route of Administration	ORAL

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

Product Characteristics
Color	gray (WHITE BAND IN THE MIDDLE)	Score	no score
Shape	OVAL (capsule shaped)	Size	20mm
Flavor		Imprint Code	G18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-623-71	7 in 1 CARTON	01/02/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 62207-623-41	24 in 1 CONTAINER; Type 0: Not a Combination Product	01/02/2024
3	NDC: 62207-623-57	90 in 1 CONTAINER; Type 0: Not a Combination Product	01/02/2024
4	NDC: 62207-623-45	225 in 1 CONTAINER; Type 0: Not a Combination Product	01/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	01/02/2024

Labeler - Granules India Limited (915000087)