Spl Patient Package Insert
Drug Facts
Loratadine 10mg Tablet
FDA Label NDC 21130-932
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Loratadine 10mg (NDC 21130-932). 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 spl patient package insert, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
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
Warnings
Warnings
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 (1-800-222-1222).
Dosage & Administration
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 Safety Information
Other information
- Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
- store between 20° to 25° C (68° to 77° F)
- FDA approved dissolution test specifications differ from USP
Inactive Ingredient
Inactive ingredients
colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
732R Loratadine 10mg Tablets, 365ct label
732R Loratadine 10mg Tablets, 365ct carton
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