Active Ingredient(In Each Tablet)
Loratadine 10 mg
Loratadine Tablet
FDA Label NDC 37835-621
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Loratadine (NDC 37835-621). 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 active ingredient(in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 useif you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use ifyou haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask doctor ifan 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 (1-800-222-1222) 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 |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate
Questions?
call toll free 1-844-912-4012
Other
Distributed by:
BI-MART
Eugene, OR 97402
Principal Display Panel-10 Tablets
NDC 37835-621-10
Compare to the Active Ingredient in Claritin ®*
Non-Drowsy**
Allergy Relief
Loratadine 10 mg/Antihistamine
24 Hour Allergy
Relief of:
- Sneezing, runny nose
- Itchy, watery eyes
- Itchy throat or nose
Original Prescription Strength
**When Taken as Directed. See Drug Facts Panel.
10 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®
10 (Label 10)
Principal Display Panel-30 Tablets
NDC 37835-621-30
Compare to the Active Ingredient in Claritin ®*
Non-Drowsy**
Allergy Relief
Loratadine 10 mg/Antihistamine
24 Hour Allergy
Relief of:
- Sneezing, runny nose
- Itchy, watery eyes
- Itchy throat or nose
Original Prescription Strength
**When Taken as Directed. See Drug Facts Panel.
30 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®
30 (Label 30)
Principal Display Panel-100 Tablets
NDC 37835-621-01
Compare to the Active Ingredient in Claritin ®*
Non-Drowsy**
Allergy Relief
Loratadine 10 mg/Antihistamine
24 Hour Allergy
Relief of:
- Sneezing, runny nose
- Itchy, watery eyes
- Itchy throat or nose
Original Prescription Strength
**When Taken as Directed. See Drug Facts Panel.
100 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®
100 (Label 100)
* Please review the disclaimer below.
