Loratadine Tablet
FDA Label NDC 48433-064

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safecor Health, Llc for the product Loratadine (NDC 48433-064). 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, 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

Active Ingredient

(in each tablet)

Loratadine USP, 10 mg

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.

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 of kidney disease

ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
    TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
  • protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions Or Comments?

call 1-800-447-1006

  • Serious side effects associated with use of this product may be reported to this number.

    • Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in India

    Code No.: MH/DRUGS/25/NKD/89

    Distributed by:
    Safecor Health LLC
    Rockford, IL 61103 U.S.A.

Package Label.Principal Display Panel

PRODUCT PACKAGING

NDC 48433-064-20

Loratadine
Tablets USP, 10 mg

Antihistamine

Original Prescription StrengthNon-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief(See Uses section of Patient Information)

*When taken as directed. See Patient Information.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Loratadine Tablets, Usp 10 mg Unit Carton Label (Image 01)

Loratadine Tablets, Usp 10 mg Unit Carton Label (Image 01)

Unit Carton (Image 02)

Unit Carton (Image 02)

* Please review the disclaimer below.