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Loratadine drug information

LORATADINE
Bryant Ranch Prepack · ORAL

Product NDC: 71335-2431

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameLORATADINE
Labeler / manufacturerBryant Ranch Prepack
RouteORAL
Drug classDrug class not supplied in source label
Product NDC71335-2431
Label effective date2025-06-13

Official product label reference

Loratadine — Bryant Ranch Prepack

This page contains 16 source sections for LORATADINE, oral route. Label set 0d74af21-3ef7-418b-a2ef-78737b0af288, version 2.

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

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

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
Active ingredient
ACTIVE INGREDIENT(S) Loratadine 10 mg
Do not use
DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients
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 DOCTOR IF an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast feeding
PREGNANCY/BREASTFEEDING 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 right away.
Unclassified section
OTHER INFORMATION Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken QUESTIONS OR COMMENTS Contact 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.
Storage and handling
STORAGE store between 20º to 25ºC (68º to 77ºF)
Inactive ingredient
INACTIVE INGREDIENTS Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized
Recent major changes
Supply and packaging
HOW SUPPLIED Loratadine 10 mg NDC 71335-2431-1: 20 Tablets in a BOTTLE NDC 71335-2431-2: 30 Tablets in a BOTTLE NDC 71335-2431-3: 60 Tablets in a BOTTLE NDC 71335-2431-4: 14 Tablets in a BOTTLE NDC 71335-2431-5: 10 Tablets in a BOTTLE NDC 71335-2431-6: 90 Tablets in a BOTTLE NDC 71335-2431-7: 28 Tablets in a BOTTLE NDC 71335-2431-8: 15 Tablets in a BOTTLE NDC 71335-2431-9: 100 Tablets in a BOTTLE Store between 20º to 25ºC (68º to 77ºF). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Official sources and product identifiers

Substances listed: LORATADINE

RxNorm identifiers: 311372

Package NDC codes

71335-2431-1, 71335-2431-2, 71335-2431-3, 71335-2431-4, 71335-2431-5, 71335-2431-6, 71335-2431-7, 71335-2431-8, 71335-2431-9

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.