Loratadine Capsule, Liquid Filled
FDA Label NDC 25000-021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Loratadine (NDC 25000-021). 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), warnings, ask a doctor before use if, when using this product, stop use and ask doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)


Loratadine  10mg



Purpose

Antihistamine

Use(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

• runny nose

• sneezing

• itchy, water eyes

• 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 Doctor If

an allergic reaction to this product occurs. Seek medical help right away

Pregnancy/Breastfeeding

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 capsule daily; Not more than 1 capsule in 24 hours.
Children under 6 years of age: ask a doctor.
Consumers with Liver or kidney disease: ask a doctor.

Inactive Ingredients

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Storage

Store at 20°-25°C (68°-77°F).

Protect from freezing.

Safely sealed: do not use if the safety seal is open or torn.

Principal Display Panel

NDC# 25000-021-13
Loratadine Capsules, 10 mg
600 counts Bottle Label







NDC# 25000-021-34
Loratadine Capsules, 10 mg
28 counts Blister Pack




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