Loratadine Allergy Relief Tablet
FDA Label NDC 53943-975

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Loratadine Allergy Relief (NDC 53943-975). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy 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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

Other

DISTRIBUTED BY
DRUG MART-FOOD FAIR
MEDINA, OHIO 44256

Principal Display Panel - 10 Mg Tablet Bottle Label

DISCOUNT
drug
mart
FOOD FAIR

Non-Drowsy†

Allergy Relief

Loratadine
Tablets USP, 10 mg

Antihistamine
Indoor & Outdoor Allergies

RELIEF OF: Sneezing; Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

24 Hour Allergy Relief

60 Tablets

†When taken as directed. See Drug Facts Panel.

Principal Display Panel (10 mg Tablet Bottle Label)

Principal Display Panel (10 mg Tablet Bottle Label)

* Please review the disclaimer below.