Active Ingredient(S)
Fexofenadine HCl 180 mg
Allergy Relief Capsule, Coated
FDA Label NDC 69168-413
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 69168-413). 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
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
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 180 mg caplet with water, once a day; do not take more than 1 caplet 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
- protect from excessive moisture
- do not use if imprinted seal under safety cap is broken or missing [for bottle]
- do not use if blister unit is torn or open [for blister]
Storage
store at room temperature 20°– 25°C (68°– 77°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide),
hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Allergy Relief (413 Allery Relief 1)
Allergy Relief (413 Allery Relief 2)
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