Fexofenadine HCL FEXOFENADINE HCL AKRON PHARMA INC. FDA Approved USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
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Route
ORAL
Applications
ANDA204507

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(S) in each tablet Fexofenadine hydrochloride USP 180 mg
Inactive Ingredients
INACTIVE INGREDIENTS anhydrous lactose colloidal silicon dioxide corn starch croscarmellose sodium lactose monohydrate pregelatinized starch(maize) stearic acid opadry pink 03B84893 containing hypromellose polyethylene glycol red iron oxide titanium dioxide and yellow iron oxide.
Strengths
180 mg
Treats Conditions
Use S Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat
Pill Appearance
Shape: capsule Color: pink Imprint: SG;202

Identifiers & Packaging

Container Type UNKNOWN
UPC
0377399204235 0371399804211
UNII
2S068B75ZU
Packaging

HOW SUPPLIED SECTION Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT NDC: 71399-8042-3 Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT NDC: 71399-8042-1; 30CT 100CT

Package Descriptions
  • HOW SUPPLIED SECTION Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT NDC: 71399-8042-3 Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT NDC: 71399-8042-1
  • 30CT 100CT

Overview

USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Indications & Usage

USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

DIRECTIONS 60 mg adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 180 mg 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

Warnings & Precautions
WARNINGS
Purpose

PURPOSE Antihistamine

Do Not Use

DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients.

When Using

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 & Ask a Doctor

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

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

QUESTIONS OR COMMENTS Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in U.S.A


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