Active Ingredient (In Each Tablet)
Loratadine, USP 10 mg
Allergy Relief
FDA Label NDC 71335-1461
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Allergy Relief (NDC 71335-1461). 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, do not use, ask a doctor before use if you have, when using this product,, stop use and ask a doctor if, if pregnant 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
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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,
do not take more than directed. Taking more than directed may cause drowsiness.
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 (1-800-222-1222)
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 at 20°-25°C (68°-77°F) (see UPS Controlled Room Temperature)
Inactive Ingredients
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-888-588-1418 Monday-Friday 9AM-5PM EST
How Supplied
Product: 71335-1461
NDC: 71335-1461-1 20 TABLET in a BOTTLE
NDC: 71335-1461-2 30 TABLET in a BOTTLE
NDC: 71335-1461-3 60 TABLET in a BOTTLE
NDC: 71335-1461-4 14 TABLET in a BOTTLE
NDC: 71335-1461-5 10 TABLET in a BOTTLE
NDC: 71335-1461-6 90 TABLET in a BOTTLE
NDC: 71335-1461-7 28 TABLET in a BOTTLE
NDC: 71335-1461-8 15 TABLET in a BOTTLE
NDC: 71335-1461-9 100 TABLET in a BOTTLE
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