Loratadine Tablet
FDA Label NDC 60505-0147

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotex Corp. for the product Loratadine (NDC 60505-0147). 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, directions, other information, inactive ingredients, principal display panel - 10 mg, 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)

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 10 Mg

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
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

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

safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
store between 2° and 30°C (36° and 86°F)
protect from exceesive moisture