Allergy Relief
413 - Allery Relief
25e72bd3-25c6-4943-92bb-27f9543e2d8a
HUMAN OTC DRUG LABEL
Mar 23, 2021
Allegiant Health
DUNS: 079501930
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexofenadine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel

Allergy Relief
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(s)
Fexofenadine HCl 180 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
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.
DOSAGE & ADMINISTRATION SECTION
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
SPL UNCLASSIFIED SECTION
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 AND HANDLING SECTION
Storage
store at room temperature 20°– 25°C (68°– 77°F)
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM