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, 5 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
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

WARNINGS SECTION

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

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

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

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

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

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	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

OTHER SAFETY INFORMATION

• Phenylketonurics: contains phenylalanine 1.25 mg per tablet.
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20° to 25°C (68° and 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

Keep the carton. It contains important information. See end panel for expiration date.

Distributed by:

SPL UNCLASSIFIED SECTION

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0418

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-996-30

^†Compare to the active ingredient of Children’s Claritin® Chewables

ages 2 years and older

Non-Drowsy

Children’s Allergy Relief

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Grape Flavored

24 Hour Relief Of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

^*When taken as directed. See Drug Facts Panel.

DailyMed RxNorm Mappings#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

• Loratadine
• ASPARTAME
• ANHYDROUS CITRIC ACID
• SILICON DIOXIDE
• D&C RED NO. 27
• FD&C BLUE NO. 2
• MAGNESIUM STEARATE
• MANNITOL
• MICROCRYSTALLINE CELLULOSE
• STEARIC ACID
• 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 · 11 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 · 2 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 · 49 observed states.

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Reported adverse events (FAERS/openFDA)#

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