FEXOFENADINE HYDROCHLORIDE tablet

FEXOFENADINE HYDROCHLORIDE by

Drug Labeling and Warnings

FEXOFENADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

Warnings

DO NOT USE

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

ASK DOCTOR

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

WHEN USING

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 SAFETY INFORMATION

Other information  store between 20º and 25ºC (68º and 77ºF)  protect from excessive moisture

INACTIVE INGREDIENT

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, povidone, pregelatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.

Questions or comments?

Call 1 (732) 994-2808 or email support@gencare.health

This product is not manufactured or distributed by Chattem, Inc, a Sanofi Company, owner of the registered trademark Allegra® Allergy.

SPL UNCLASSIFIED SECTION

Distributed by: Gencare Consumer Products, LLC
40E Cotters Ln, Suite A,
East Brunswick, NJ 08816

NDC:

72090-010-03; 50s HDPE Bottle

NDC:

72090-010-04; 150s HDPE Bottle

NDC:

72090-010-02; 100s HDPE Bottle

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-010
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-010-03	50 in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2024
2	NDC: 72090-010-04	150 in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2024
3	NDC: 72090-010-02	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210137	10/03/2024

Labeler - Pioneer Life Sciences, LLC (014092742)

Registrant - Pioneer Life Sciences, LLC (014092742)