SPL v1
SPL
SPL Set ID 2de81a41-8488-7e39-e063-6294a90a394b
Route
ORAL
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Povidone, Unspecified Hypromelloses Magnesium Stearate Microcrystalline Cellulose Croscarmellose Titanium Dioxide Brown Iron Oxide Starch, Corn Silicon Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 018;E Shape: oval Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18

Description

Product Repackaged and Distributed with permission of manufacturer by: Select Corporation Carrollton, TX 75007


Medication Information

Warnings and Precautions

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.

Indications and Usage

Antihistamine

Dosage and Administration

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

Dosage Forms and Strengths

Supplied as one solid tablet of Fexondendaine Hcl 180mg

Description

Product Repackaged and Distributed with permission of manufacturer by: Select Corporation Carrollton, TX 75007

Section 42229-5

Product Repackaged and Distributed

with permission of manufacturer by:

Select Corporation Carrollton, TX 75007

Section 50565-1

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

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Section 51945-4

Allegra®

ALLERGY

fexofenadine HCl tablet

180 mg/antihistamine

24HR

NON-DROWSY

INDOOR / OUTDOOR

ALLERGY RELIEF

2111920120.A

✓Sneezing

✓Runny Nose

✓Itchy, Watery Eyes

✓Itchy Nose or Throat

1 TABLET

Actual Size

Section 53413-1

call toll-free 1-800-633-1610 or www.allegra.com

Section 53414-9

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

Section 55105-1

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 55106-9

Fexofenadine HCl 180 mg

Section 60561-8

safety sealed: do not use if the individual blister unit is torn or opened

store between 20° and 25°C (68° and 77°F)

protect from excessive moisture


Structured Label Content

Indications and Usage (34067-9)

Antihistamine

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

Supplied as one solid tablet of Fexondendaine Hcl 180mg

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Product Repackaged and Distributed

with permission of manufacturer by:

Select Corporation Carrollton, TX 75007

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.

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Section 51945-4 (51945-4)

Allegra®

ALLERGY

fexofenadine HCl tablet

180 mg/antihistamine

24HR

NON-DROWSY

INDOOR / OUTDOOR

ALLERGY RELIEF

2111920120.A

✓Sneezing

✓Runny Nose

✓Itchy, Watery Eyes

✓Itchy Nose or Throat

1 TABLET

Actual Size

Section 53413-1 (53413-1)

call toll-free 1-800-633-1610 or www.allegra.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Fexofenadine HCl 180 mg

Section 60561-8 (60561-8)

safety sealed: do not use if the individual blister unit is torn or opened

store between 20° and 25°C (68° and 77°F)

protect from excessive moisture


Advanced Ingredient Data


Raw Label Data

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