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 NDC71335-2551
Label effective date2025-01-21
Official product label reference
Loratadine — Bryant Ranch Prepack
This page contains 15 source sections for LORATADINE, oral route. Label set 7f97595b-9df7-4834-82f0-5e4ce329c118, version 1.
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 itchy, watery eyes sneezing itching of the nose or throat
Table text from source:
| 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
Active ingredient
ACTIVE INGREDIENT(S) Active ingredient (in each tablet) Loratadine USP, 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.
Ask a doctor or pharmacist
ASK A DOCTOR OR PHARMACIST BEFORE USE IF
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 Bottles: Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken store between 20° to 25°C (68° to 77°F) Blisters packs: safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn store between 20° to 25°C (68° to 77°F) protect from excessive moisture
QUESTIONS OR COMMENTS? Call 1-888-588-1418
HOW SUPPLIED Loratadine USP, 10 mg: color white (White to Off white) and the imprint code is H;L20. NDC: 71335-2551-1: 20 Tablets in a BOTTLE NDC: 71335-2551-2: 30 Tablets in a BOTTLE NDC: 71335-2551-3: 60 Tablets in a BOTTLE NDC: 71335-2551-4: 14 Tablets in a BOTTLE NDC: 71335-2551-5: 10 Tablets in a BOTTLE NDC: 71335-2551-6: 90 Tablets in a BOTTLE NDC: 71335-2551-7: 28 Tablets in a BOTTLE NDC: 71335-2551-8: 15 Tablets in a BOTTLE NDC: 71335-2551-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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.