Other
Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007
Allegra Allergy 24 Hour Tablet, Film Coated
FDA Label NDC 85237-1920
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Consumer Group for the product Allegra Allergy 24 Hour (NDC 85237-1920). 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 other, inactive ingredient, otc - active ingredient, warnings, dosage & administration, otc - questions, other safety information, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide
Otc - Active Ingredient
Fexofenadine HCl 180 mg
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 right away.
Dosage & Administration
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
Otc - Questions
call toll-free 1-800-633-1610 or www.allegra.com
Other Safety Information
safety sealed: do not use if the individual blister unit is torn or opened
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
Indications & Usage
Antihistamine
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Purpose
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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
How Supplied
Supplied as one solid tablet of Fexondendaine Hcl 180mg
Package Label.Principal Display Panel
Allegra Allergy 1 Tablet (Allegra)
ALLERGY
fexofenadine HCl tablet
180 mg/antihistamine
24HR
NON-DROWSY
INDOOR / OUTDOOR
ALLERGY RELIEF
2111920120.A
✓Sneezing
✓Runny Nose
✓Itchy, Watery Eyes
✓Itchy Nose or Throat
1 TABLET
Actual Size
* Please review the disclaimer below.
