Active Ingredient (In Each Tablet)
Fexofenadine HCl 180 mg
Fexofenadine Hydrochloride
FDA Label NDC 68210-0122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Fexofenadine Hydrochloride (NDC 68210-0122). 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 (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a
different dose.
Otc - 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)
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
medical help right away. You may report side effects to FDA at
1-800-FDA-1088.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 |
Other Safety Information
Other information safety sealed: do not use if printed foil inner
seal on bottle is torn or missing store between 20° and 25°C (68°
and 77°F) protect from excessive moisture
Inactive Ingredient
Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.
Otc - Questions
Questions or comments? call +1-888-333-9792
Other
Distributed by:
Spirit Pharmaceuticals LLC,
Ronkonkoma, NY 11779
ORG 03/19
Manufactured by:
Unique Pharmaceutical
Laboratories
(A Div. of J. B. Chemicals &
Pharmaceuticals Ltd.)
Mumbai 400 030, India
Mfg. Lic. No.: G/1430
Principal Display Panel
Valumeds™
NDC 68210-0122-1
non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine
24 Hour
indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat
100 tablets
Actual Size
* Please review the disclaimer below.
