FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Fexofenadine HCl USP 180 mg
Inactive Ingredient
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregalatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide
Dosage & Administration
- adults & 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
Indications & Usage
temporarily relieves these symptoms due to hay fever or other 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.
- kidney disease. Your doctor should determine if you need a different dose.
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices
Ask a doctor before use if you have
When using this product
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
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning: Taking more than directed can cause serious health problems. Incase of overdose, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Antihistamine
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- protect from excessive moisture
- each tablet contains: sodium 8.2 mg
- this product meets the requirements of USP Dissolution Test 2
Tamper Evident: Do not use if package is opened or if blister unite is torn broken or shows any signs of tampering.
Package Label.Principal Display Panel
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