Active Ingredient(S), In Each Tablet
Fexofenadine hydrochloride USP, 180 mg
Fexofenadine Hcl Tablet
FDA Label NDC 71399-8042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Fexofenadine Hcl (NDC 71399-8042). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), in each tablet, purpose, use(s), do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients.
Ask A Doctor Before Use If
you have kidney disease. Your doctor should determine if you need a different dose.
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.
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 |
Other Information
- Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
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.
How Supplied Section
Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT
NDC: 71399-8042-1
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
Principal Display Panel
Fexofenadine Hydrochloride Tablets, USP 180 mg 100s Container Label
Fexofenadinetabconlabel30s (Fexofenadinehcl 180mg 100count)
* Please review the disclaimer below.
