Cvs Fexofenadine Hydrochloride

Cvs Fexofenadine Hydrochloride
SPL v3
SPL
SPL Set ID 3d6c7b10-ed05-bbde-e063-6294a90ae92f
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Ferric Oxide Red Silicon Dioxide Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: 180 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2025-10-22

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

Warnings

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 printed safety seal under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Package Labeling:

Inactive Ingredients

colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregenatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.

Questions Or Comments?

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

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. (1-800-222-1222)

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

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

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 printed safety seal under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregenatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.

Questions Or Comments? (Questions or comments?)

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

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.

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. (1-800-222-1222)

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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