Loratadine Odt
FDA Label NDC 68016-527

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Loratadine Odt (NDC 68016-527). 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

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 (1-800-222-1222).

Directions

  • place 1 tablet on tongue; tablet disintegrates, with or without water

    • 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

  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

Inactive Ingredients

aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

Principal Display Panel

Premier Value®

NDC 68016-527-31

Original Prescription Strength

NON-DROWSY*

24 Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Allergy Relief

Antihistamine

Indoor & Outdoor Allergies

No water needed. Melts in your mouth.

Relief of:

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat or Nose

    • For Adults and Children six years and older!

    30 ORALLY DISINTEGRATING TABLETS

    COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN®REDITABS®†

    *When taken as directed. See Drug Facts Panel.

    †This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.

    This Is The 30 Count Blister Carton Label For Premier Value Loratadine Odt, Usp 10 mg. (Loraodt)

    This Is The 30 Count Blister Carton Label For Premier Value Loratadine Odt, Usp 10 mg. (Loraodt)

* Please review the disclaimer below.