Active Ingredient(S)
Loratadine, USP 10 mg
Loratadine Allergy Relief Tablet
FDA Label NDC 67091-245
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 Loratadine Allergy Relief (NDC 67091-245). 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(s), purpose, use(s), 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
Use(S)
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 and kidney disease | ask a doctor |
Other Information
- store between 20° to 25° C (68° to 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.
Inactive Ingredients
Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions?
or to report an adverse event call 800-824-7984 Monday - Friday 9am - 4pm MST
Principal Display Panel
Compare to the active ingredient in CLARITIN®
When taken as directed. See Drug Facts Panel.
WinCo FOODS
24 Hour
NON-DROWSY
Allergy Relief
Indoor & Outdoor Allergies
LORATADINE TABLETS, USP10 mg/ANTIHISTAMINE
Original Prescription Strength
Relief of:
10 Tablets
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
5113359/0914
Compare to the active ingredient in CLARITIN®
When taken as directed. See Drug Facts Panel.
WinCo FOODS
24 Hour
NON-DROWSY
Allergy Relief
Indoor & Outdoor Allergies
LORATADINE TABLETS, USP10 mg/ANTIHISTAMINE
Original Prescription Strength
Relief of:
30 Tablets
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
5113370/0914
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