Loratadine Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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:

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

• store between 20° to 25° C (68° to 77° F)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

HOW SUPPLIED

How Supplied Section

NDC: 71335-0100-1: 20 Tablets in a BOTTLE

NDC: 71335-0100-2: 30 Tablets in a BOTTLE

NDC: 71335-0100-3: 60 Tablets in a BOTTLE

NDC: 71335-0100-4: 14 Tablets in a BOTTLE

NDC: 71335-0100-5: 10 Tablets in a BOTTLE

NDC: 71335-0100-6: 90 Tablets in a BOTTLE

NDC: 71335-0100-7: 28 Tablets in a BOTTLE

NDC: 71335-0100-8: 15 Tablets in a BOTTLE

NDC: 71335-0100-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine 10mg Tablet

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

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Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

• Loratadine Allergy Relief
• 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.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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 · 43 observed states.

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Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

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