Fexofenadine Hydrochloride Tablets, Usp 180 Mg

Fexofenadine Hydrochloride Tablets, Usp 180 Mg
SPL v1
SPL
SPL Set ID 2a578643-adc1-44ca-83f2-9d48527bd3a4
Route
ORAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Croscarmellose Sodium Starch, Corn Magnesium Stearate Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol 400 Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: 545 Shape: oval Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-14

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

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

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 53414-9

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

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.

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)
Active Ingredient (in Each Tablet)

Fexofenadine HCl, USP 180 mg

Principal Display Panel 180 Mg Tablet Bottle Carton

NDC 46122-779-66

Compare to

Allegra® Allergy

active ingredient*

GOOD

NEIGHBOR

PHARMACY®

NON-DROWSY

Fexofenadine

Hydrochloride

Tablets, USP

180 mg

Antihistamine

Indoor & Outdoor Allergies

Allergy

24 Hours

Relief of:

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

90 Tablets


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

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 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 53414-9 (53414-9)

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

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
Other Information (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 (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? (Questions or comments?)

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

When Using This Product (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)
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl, USP 180 mg

Principal Display Panel 180 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton)

NDC 46122-779-66

Compare to

Allegra® Allergy

active ingredient*

GOOD

NEIGHBOR

PHARMACY®

NON-DROWSY

Fexofenadine

Hydrochloride

Tablets, USP

180 mg

Antihistamine

Indoor & Outdoor Allergies

Allergy

24 Hours

Relief of:

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

90 Tablets


Advanced Ingredient Data


Raw Label Data

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