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 2018-06-01

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 5 mg

Uses

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

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.

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

Questions?

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

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

Distributed By:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0619

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° and 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

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).

Active Ingredient (in Each Tablet)

Loratadine USP, 5 mg

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton

NDC 51660-753-31

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

ages 2 years and older

Children’s

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Grape Flavored

Non-Drowsy*

24 Hour Relief Of:

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

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

^†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Structured Label Content

Uses

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

Purpose

Antihistamine

Warnings

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.

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

Questions?

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

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

Distributed By: (Distributed by:)

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0619

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° and 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

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).

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

Loratadine USP, 5 mg

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton

NDC 51660-753-31

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

ages 2 years and older

Children’s

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Grape Flavored

Non-Drowsy*

24 Hour Relief Of:

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

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

^†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "Purpose": "Antihistamine", "Warnings": "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.", "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", "Questions?": "call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date.", "Distributed by:": "Ohm Laboratories Inc. New Brunswick, NJ 08901 0619", "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° and 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", "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).", "Active ingredient (in each tablet)": "Loratadine USP, 5 mg", "Principal Display Panel – 30 Chewable Tablet Blister Pack Carton": "NDC 51660-753-31 † Compare to the active ingredient of Children’s Claritin® Chewable ages 2 years and older Children’s Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Grape Flavored Non-Drowsy* 24 Hour Relief Of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat * When taken as directed. See Drug Facts Panel. † Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information