Active Ingredient(S)
Fexofenadine HCl 60mg
Allergy Relief Tablet, Film Coated
FDA Label NDC 69168-437
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Allergy Relief (NDC 69168-437). 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), purpose, use(s), do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, 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
- itchy, watery eyes
- sneezing
- 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.
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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
- store at room temperature 20°– 25°C (68°– 77°F)
- protect from excessive moisture
- do not use if imprinted seal under safety cap is broken or missing
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron
oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene
glycol, pregelatinized starch, purified water, titanium dioxide
Questions
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Fexo 60mg (437 Allergy Relief 1)
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