Allergy Relief Fexofenadine Hydrochlroride Tablets 180 Mg

SPL v3

SPL

SPL Set ID 0a4f4178-bea5-4995-99dc-96980cccdc8a

Route

ORAL

Published

Effective Date 2024-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Ferric Oxide Yellow Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Ferric Oxide Red Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: orange Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2024-10-03

Description

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg

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

Section 42229-5

Distributed by: Gencare Consumer Products, LLC

40E Cotters Ln, Suite A,

East Brunswick, NJ 08816

Section 50565-1

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.

Section 50566-9

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

Section 50567-7

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)

Section 50569-3

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

Section 50570-1

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

Section 51727-6

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.

Section 53414-9

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

Section 60561-8

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

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

Questions Or Comments?

Call 1 (732) 994-2808 or email [email protected]

Ndc 72090 010 03; 50s Hdpe Bottle

Active Ingredient (in Each Caplet)

Fexofenadine HCl 180 mg

Ndc 72090 010 02; 100s Hdpe Bottle

Ndc 72090 010 04; 150s Hdpe Bottle

Structured Label Content

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

Section 42229-5 (42229-5)

Distributed by: Gencare Consumer Products, LLC

40E Cotters Ln, Suite A,

East Brunswick, NJ 08816

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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)

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

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

Purpose

Antihistamine

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

Questions Or Comments? (Questions or comments?)

Call 1 (732) 994-2808 or email [email protected]

Ndc 72090 010 03; 50s Hdpe Bottle (NDC 72090-010-03; 50s HDPE Bottle)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Fexofenadine HCl 180 mg

Ndc 72090 010 02; 100s Hdpe Bottle (NDC 72090-010-02; 100s HDPE Bottle)

Ndc 72090 010 04; 150s Hdpe Bottle (NDC 72090-010-04; 150s HDPE Bottle)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Distributed by: Gencare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816", "50565-1": "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.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "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)", "50569-3": "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "51727-6": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "60561-8": "Other information  store between 20º and 25ºC (68º and 77ºF)  protect from excessive moisture", "Purpose": "Antihistamine", "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", "Questions or comments?": "Call 1 (732) 994-2808 or email support@gencare.health", "Active ingredient (in each caplet)": "Fexofenadine HCl 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.224432 · Updated: 2026-03-14T23:11:53.041179