Official product label reference

Loratadine — YYBA CORP

This page contains 14 source sections for LORATADINE, oral route. Label set 5a71de5c-a844-9dd4-e063-6294a90af015, version 1.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purpose Antihistamine

Dosage and administration — label text

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 Table text from source: | 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

Warnings

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

Unclassified section

Drug Facts

Active ingredient

Active ingredient (in each tablet) Loratadine USP 10 mg

Ask a doctor before use

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

While using this medicine

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

When to stop use and seek help

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

Pregnancy or breast feeding

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

Child safety

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Storage and handling

Other information Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken store at 20° to 25°C (68° to 77°F) protect from excessive moisture

Inactive ingredient

Inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions

Questions or comments? call 1-866-933-6337

Official sources and product identifiers

DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
Drugs@FDA application ANDA208314Application history where available; verify the specific product and indication.

Substances listed: LORATADINE

RxNorm identifiers: 311372

Package NDC codes

73581-229-01, 73581-229-03

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.

Loratadine drug information