Loratadine Tablets, USP Antihistamine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

• itching of the nose or throat
• runny nose
• itchy, watery eyes
• sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Overbagged with 10 tablets per bag, NDC 55154-4976-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

OTC - QUESTIONS SECTION

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging, Columbus, Ohio 43217

Distributed By:

Cardinal Health

Dublin, OH 43017

L4955647-10924 / L4955647-20924

801697

0224801/0119

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-4976-0

NON-DROWSY* 24 Hour Allergy Relief

LORATADINE TABLETS, USP 10 mg

Antihistamine

10 TABLETS

Product Linked Resources#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

• Loratadine
• STARCH, CORN
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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Source XML

Older Hydrated Versions#

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

Orange Book application contexts#

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Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.