Non-drowsy

Non-drowsy
SPL v4
SPL
SPL Set ID 0eaf28a5-f8dd-3888-e063-6394a90a8cc6
Route
ORAL
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Ferrosoferric Oxide Silicon Dioxide Gelatin Shellac Microcrystalline Cellulose Fd&c Blue No. 1 Titanium Dioxide Polyethylene Glycol 8000 Magnesium Stearate Ammonia D&c Red No. 33 Hypromellose 2910 (3 Mpa.s) Hydroxypropyl Cellulose (90000 Wamw) Starch, Corn Propylene Glycol Croscarmellose Sodium Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: G18 Shape: oval Color: gray Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2024-07-23

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Other Information

■ safety sealed: do not use if imprinted safety seal under cap is broken or missing

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

■ protect from excessive moisture

Inactive Ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,

pregelatinized starch, propylene glycol, shellac, titanium dioxide

Questions Or Comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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)

Prrincipal Display Panel

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.

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient ​(in Each Tablet)

Fexofenadine HCl USP, 180 mg


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

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)

■ safety sealed: do not use if imprinted safety seal under cap is broken or missing

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

■ protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,

pregelatinized starch, propylene glycol, shellac, titanium dioxide

Questions Or Comments? (Questions or comments?)

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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)

Prrincipal Display Panel (Prrincipal display panel)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant 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 right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient ​(in Each Tablet) (Active ingredient ​(in each tablet))

Fexofenadine HCl USP, 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)