Loratadine Allergy Relief Tablet
FDA Label NDC 63629-7772

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Loratadine Allergy Relief (NDC 63629-7772). 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

Active Ingredient(S)

Loratadine USP, 10 mg

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.

Directions

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver and kidney diseaseask 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

How Supplied

Product: 63629-7772

NDC: 63629-7772-1 20 TABLET in a BOTTLE

NDC: 63629-7772-2 30 TABLET in a BOTTLE

NDC: 63629-7772-3 60 TABLET in a BOTTLE

NDC: 63629-7772-4 14 TABLET in a BOTTLE

NDC: 63629-7772-5 10 TABLET in a BOTTLE

NDC: 63629-7772-6 90 TABLET in a BOTTLE

NDC: 63629-7772-7 28 TABLET in a BOTTLE

NDC: 63629-7772-8 15 TABLET in a BOTTLE

NDC: 63629-7772-9 100 TABLET in a BOTTLE

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