Cvs Loratadine Tablet
FDA Label NDC 51316-184

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Loratadine (NDC 51316-184). 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, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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 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

Warnings

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

 adults and children 6 years of age 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

  • safety sealed: do not use if printed safety seal under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions Or Comments?

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