Active Ingredient (In Each Tablet)
Loratadine, USP 10 mg
Allergy Relief Tablet
FDA Label NDC 67091-350
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Allergy Relief (NDC 67091-350). 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 (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 at 20°-25°C (68°-77°F) (see UPS Controlled Room Temperature
- protect from light
Inactive Ingredients
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-800-824-1706 Monday-Friday 9AM-4PM MST
Principal Display Panel
†When taken as directed. See Drugs Facts Panel.
*Compare to the active ingredient in CLARITIN® 24 HOUR
24 HOUR NON-DROWSY†
Allergy Relief
Indoor & Outdoor Allergies
Original Prescription Strength
Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat or Nose
LORATADINE TABLETS,
USP 10 mg / ANTIHISTAMINE
Tablets
*This product is not manufactured or distributed by BAYER HEALTHCARE LLC, distributor of CLARITIN®. 24 HOUR.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, IS 83704
Package Label
WINCO FOODS Allergy Relief
* Please review the disclaimer below.
