Fexofenadine Hcl Tablets, Usp 180mg

Fexofenadine Hcl Tablets, Usp 180mg
SPL v6
SPL
SPL Set ID 16de2c5d-b27b-9fb4-e063-6394a90a8390
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
D&c Red No. 28 Cellulose, Microcrystalline Gelatin Hypromelloses Fd&c Blue No. 1 D&c Red No. 33 Titanium Dioxide Croscarmellose Sodium Magnesium Stearate Starch, Corn Polyethylene Glycol 6000 Hydroxypropyl Cellulose (1600000 Wamw)

Identifiers & Packaging

Pill Appearance
Imprint: G18 Shape: oval Color: gray Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2024-07-01

Description

Fexofenadine HCl USP, 180mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180mg

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 ask a doctor

and older

consumers with kidney ask a doctor

disease

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

Principal Display Panel

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, 180mg

Ask A Doctor Before Use If You Have

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


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

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 ask a doctor

and older

consumers with kidney ask a doctor

disease

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

Principal Display Panel

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, 180mg

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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