Dye-Free Children's Loratadine Chewable Tablets USP, 5 mg

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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
• 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

• chew or crush tablets completely before swallowing.

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, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Signature
care_®
Quality
Guaranteed

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

NDC 21130-646-20

24 Hour | Non-Drowsy*
Children's Allergy Relief
AGES 2 YEARS & OLDER
LORATADINE CHEWABLE TABLETS USP, 5 mg Antihistamine

DYE FREE | GRAPE FLAVOR

• Indoor & outdoor allergies
• Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat or nose

*When taken as directed. See Drug Facts Panel.

The chewable tablets are to be chewed before swallowing.

Actual Size

20 CHEWABLE
TABLETS

DailyMed RxNorm Mappings#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• DYE-FREE CHILDRENS LORATADINE
• LORATADINE
• aspartame
• anhydrous citric acid
• silicon dioxide
• magnesium stearate
• mannitol
• microcrystalline cellulose
• sodium starch glycolate type a potato
• stearic acid

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Product history page 1 of 2 · 49 observed states.

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