Allergy Relief
DRUG FACTS
a976ad95-33d2-49f5-bad5-e980bf764879
HUMAN OTC DRUG LABEL
Aug 26, 2025
P & L Development, LLC
DUNS: 800014821
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
Product Label
READYinCASE Allergy Relief
INDICATIONS & USAGE SECTION
Uses
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 (in each tablet)
Fexofenadine HCl USP, 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 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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
- store between 20-25ºC (68-77ºF)
- protect from excessive moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
call** 1-877-753-3935**Monday-Friday 9AM-5PM EST