Loratadine

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:

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

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

OTC - STOP USE SECTION

if 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

• Safety sealed: do not use if printed foil under cap is broken or missing. (for bottle only)
• Safety sealed: do not use if the imprinted blister unit is open or torn. (for blister package only)

STORAGE AND HANDLING SECTION

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• Protect from excessive moisture. (blister unit only)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-206-7821

SPL UNCLASSIFIED SECTION

01-2016M

Distributed by McKesson

One Post Street, San Francisco, CA 94104

10 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HealthMart®

PHARMACY

NDC 62011-0258-2

compare to Claritin®

active ingredient**

loratadine tablets, USP 10 mg

antihistamine

indoor & outdoor allergies

24 hour relief of sneezing/runny nose/

itchy, watery eyes/itchy throat or nose

non-drowsy* • 24 hour

30 tablets

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

Safety sealed: do not use if printed foil under cap is broken or missing.

DailyMed Billing Units#

Products#

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

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

• Loratadine
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Reported adverse events (FAERS/openFDA)#

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