FEXOFENADINE HYDROCHLORIDE tablet, film coated

FEXOFENADINE HYDROCHLORIDE by

Drug Labeling and Warnings

FEXOFENADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by OHM LABORATORIES INC., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 (1-800-222-1222).

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 inner safety seal is torn or missing
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

†Compare To
the active ingredient of
Allegra® Allergy

NDC: 51660-998-30

NDC: 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride
Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour
Relief of:

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

ohm®

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
"SEALED for YOUR PROTECTION" IS TORN OR MISSING

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-998
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	545
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-998-30	1 in 1 CARTON	04/29/2022
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51660-998-55	1 in 1 CARTON	04/29/2022
2		150 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091567	04/29/2022

Labeler - OHM LABORATORIES INC. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650445203	MANUFACTURE(51660-998)