Children's Loratadine Chewable Tablets USP, 5 mg

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, 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

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	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

STORAGE AND HANDLING SECTION

• 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° to 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

SPL UNCLASSIFIED SECTION

Distributed By AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD
NEIGHBOR
PHARMACY^®

Compare to Children's Claritin^®
Chewables active ingredient**

NDC 46122-550-60

ages 2 years and older

Non-Drowsy*
24 HOUR

Children's
loratadine chewable tablets USP, 5 mg
antihistamine

Indoor & Outdoor Allergies

Relief of:

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

20 Chewable Tablets
The chewable tablets are to be chewed before swallowing.
*When taken as directed. See Drug Facts Panel.

actual size
grape flavor

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Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

• Childrens Loratadine
• 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 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 · 51 observed states.

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Reported adverse events (FAERS/openFDA)#

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