Other
Drug Facts
Claritin Tablet, Orally Disintegrating
FDA Label NDC 11523-7157
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Claritin (NDC 11523-7157). 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, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Loratadine 10 mg
Purpose
Antihistamine
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 - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
- place 1 tablet on tongue; tablet disintegrates, with or without water
| 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 |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
- store between 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
- complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients
anhydrous citric acid, gelatin, mannitol, mint flavor
Questions Or Comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.com
Principal Display Panel - 10 Tablet Carton
Original Prescription Strength
NDC 11523-7157-2
Non-Drowsy*
Claritin
®
RediTabs®
loratadine 10 mg/antihistamine
Indoor & Outdoor
Allergies
*When taken as directed. See Drug Facts Panel.
24
Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat
or Nose
No Water Needed
Melts in Your Mouth
10
ORALLY
DISINTEGRATING TABLETS
Principal Display Panel (10 Tablet Carton)
Principal Display Panel - 60 Tablet Twin Pack Carton
TWIN PACK
Two 30ct Cartons
60 RediTabs
®
Original Prescription Strength
NDC 11523-4329-1
Non-Drowsy*
Claritin
®
RediTabs®
loratadine 10 mg/antihistamine
Indoor & Outdoor
Allergies
*When taken as directed. See Drug Facts Panel.
24
Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat
or Nose
No Water Needed
Melts in Your Mouth
60
ORALLY
DISINTEGRATING TABLETS
Principal Display Panel (60 Tablet Twin Pack Carton)
* Please review the disclaimer below.
