FDA Label for Claritin
View Indications, Usage & Precautions
Claritin Product Label
The following document was submitted to the FDA by the labeler of this product R J General Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Claritin ®
Active ingredients (in each tablet) | Purpose |
Loratadine 10 mg | Antihistamine |
Use
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
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 liver or kidney disease. your doctor should determine if you need a different dose.
When using this product don not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask 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.
Directions
| adults and children 6 years and over | 1 tablet daily: not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumer with liver or kidney disease | ask a doctor |
Other Information
- Safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
- Store between 20 o to 25 o C (68 o to 77 o F)
- Protect from excessive moisture
Inactive Ingredients
Coen starch, lactose monohydrate, magnesium stearate
Questions And Comments?
1-800-CLARITIN(1-800-252-7484) or www.claritin.com
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
Product of Ireland
Do not use if pouch is torn or broken.
Repackaged and distributed by:
RJ General
2024 Northwest Drive
Cincinnati OH 45231
Principal Display Panel - 25 Tablet Pouch Carton
Non-Drowsy*
Claritin ®
loratadine tablets 10 mg/ antihistamine
Indoor & Outdoor Allergies
Relief of:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the throat or nose
* Please review the disclaimer below.
