Active Ingredient(S) In Each Tablet
Fexofenadine hydrochloride USP, 180 mg
Fexofenadine Hcl Tablet
FDA Label NDC 16714-899
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northstar Rxllc for the product Fexofenadine Hcl (NDC 16714-899). 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
| 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
• Tamper-Evident: Do not use if printed foil seal under cap is missing
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
Inactive Ingredients
Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
Questions?
Call 1-800-206-7821
Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Manufactured by:
Hetero Labs Limited,
Unit V, Polepally, Jadcherla,
Mahabubnagar - 509 301, India.
Mfg. Lic. No.: 50/MN/AP/2009/F/R
Issued: 11/2018
Principal Display Panel
Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container label
Fexofenadinehcl30slabel (Fexofenadinehcl30slabel)
Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container carton
Fexofenadinehcl30scarton (Fexofenadinehcl30scarton)
Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container label
Fexofenadinehcl100slabel (Fexofenadinehcl100slabel)
Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container carton
Fexofenadinehcl100scarton (Fexofenadinehcl100scarton)
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