Medicine Shoppe Loratadine Allergy Relief
FDA Label NDC 49614-170

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Medicine Shoppe International for the product Medicine Shoppe Loratadine Allergy Relief (NDC 49614-170). 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.

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

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

1800-325-1397

Principal Display Panel

The Medicine Shoppe®

NDC 49614-170-75

Non-Drowsy*

Original Prescription Strength

Loratadine Tablets USP, 10 mg

Antihistamine

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.

90 TABLETS

Compare to Claritin®active ingredient†

†This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin®.

This Is The 90 Count Blister Carton Label For Loratadine Medicine Shoppe. (Lora2)

This Is The 90 Count Blister Carton Label For Loratadine Medicine Shoppe. (Lora2)

This Is The 90 Count Bottle Carton Label For Loratadine Medicine Shoppe. (Lora3)

This Is The 90 Count Bottle Carton Label For Loratadine Medicine Shoppe. (Lora3)

* Please review the disclaimer below.