Active Ingredient
Fexofenadine HCl USP 60 mg (for 60 mg)
Fexofenadine HCl USP 180 mg (for 180 mg)
Crcle Fexofenadine Hydrochloride Tablet
FDA Label NDC 57483-240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovus Pharmaceuticals, Inc. for the product Crcle Fexofenadine Hydrochloride (NDC 57483-240). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
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
Warnings
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
| 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 (for 60 mg) take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) |
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?
call 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.
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