Non-drowsy

Non-drowsy
SPL v3
SPL
SPL Set ID 1ddad045-7706-ea7e-e063-6394a90a2a5a
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Ferric Oxide Red Ferric Oxide Yellow Silicon Dioxide Starch, Corn Titanium Dioxide Microcrystalline Cellulose Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Polyethylene Glycol 6000 Hypromellose 2910 (15 Mpa.s) Ferrosoferric Oxide

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: oval Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-25

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Pdp

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

Warnings

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

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 imprinted foil under bottle cap is opened or torn

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

􀂄 protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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)

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

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


Structured Label Content

Pdp (PDP)

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

Warnings

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

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 imprinted foil under bottle cap is opened or torn

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

􀂄 protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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)

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.

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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

Fexofenadine HCl USP, 180 mg

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.


Advanced Ingredient Data


Raw Label Data

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