Loratadine

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 753 Shape: round Color: purple Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2019-07-31

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Section 53414-9

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

Directions

•
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

•
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

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

Active Ingredient (in Each Tablet)

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton

NDC 56062-990-20

FOR AGES 2 YEARS AND OLDER

INDOOR & OUTDOOR ALLERGIES

children's allergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*

24-hour relief of:

• Sneezing • Runny nose

• Itchy, watery eyes • Itchy throat or nose

ACTUAL

SIZE

20

CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

^†Compare to the active ingredient

of Children's Claritin^® Chewables

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Directions

•
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 (Other 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° to 77° F).

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton)

NDC 56062-990-20

FOR AGES 2 YEARS AND OLDER

INDOOR & OUTDOOR ALLERGIES

children's allergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*

24-hour relief of:

• Sneezing • Runny nose

• Itchy, watery eyes • Itchy throat or nose

ACTUAL

SIZE

20

CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

^†Compare to the active ingredient

of Children's Claritin^® Chewables

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "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", "42229-5": "Drug Facts", "50565-1": "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).", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "• 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": "• 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": "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", "Active ingredient (in each tablet)": "Loratadine USP, 5 mg", "PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton": "NDC 56062-990-20 FOR AGES 2 YEARS AND OLDER INDOOR & OUTDOOR ALLERGIES children's allergy LORATADINE CHEWABLE TABLETS USP, 5 mg ANTIHISTAMINE Non-drowsy* 24-hour relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose ACTUAL SIZE 20 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. GRAPE FLAVORED *When taken as directed. See Drug Facts Panel † Compare to the active ingredient of Children's Claritin ® Chewables"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information