Active Ingredient (In Each Tablet)
Loratadine USP, 10 mg
Loratadine
FDA Label NDC 37012-526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Loratadine (NDC 37012-526). 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
- itchy, watery eyes
- sneezing
- 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 between 20 and 25° C (68 and 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients
Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions?
Call 1-800-406-7984
Principal Display Panel
SHOPKO®
†Compare to the Active Ingredient of Claritin®
Original Prescription Strength
Allergy Relief
Loratadine Tablets, USP 10 mg
Antihistamine
Non-Drowsy*
Indoor & Outdoor Allergies
24 Hour Allergy Relief
Relief of:
Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
Manufactured by: Ohm Laboratories Inc.
5093684/R0412
This Is The 10 Count Blister Carton Label For Shopko Loratadine Tablets, Usp 10 mg (Lora)
* Please review the disclaimer below.
