Children's Loratadine

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Aspartame Anhydrous Citric Acid Silicon Dioxide Magnesium Stearate Mannitol Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: LC5 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2024-03-15

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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Questions?

Call 1-800-910-6874

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, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Active Ingredient (in Each Chewable Tablet)

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton

NDC 11673-310-30

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

Ages 2+ Years/ Dye-Free

Children's Allergy

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Non-drowsy**
Indoor and outdoor allergies
24-hour relief of sneezing, runny nose, itchy, watery eyes,itchy throat or nose

up&up

**When taken as directed. See drug facts panel.

30 CHEWABLE TABLETS

THE CHEWABLE TABLETS ARE

TO BE CHEWED BEFORE SWALLOWING

GRAPE

FLAVOR

ACTUAL SIZE

30

CHEWABLE

TABLETS

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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Questions?

Call 1-800-910-6874

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, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

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

Loratadine USP, 5 mg

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

NDC 11673-310-30

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

Ages 2+ Years/ Dye-Free

Children's Allergy

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Non-drowsy**
Indoor and outdoor allergies
24-hour relief of sneezing, runny nose, itchy, watery eyes,itchy throat or nose

up&up

**When taken as directed. See drug facts panel.

30 CHEWABLE TABLETS

THE CHEWABLE TABLETS ARE

TO BE CHEWED BEFORE SWALLOWING

GRAPE

FLAVOR

ACTUAL SIZE

30

CHEWABLE

TABLETS

Advanced Ingredient Data

[{"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": "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": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "Call 1-800-910-6874", "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, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid", "Active ingredient (in each chewable tablet)": "Loratadine USP, 5 mg", "PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton": "NDC 11673-310-30 Compare to active ingredient in Children's Claritin ® Chewables* Ages 2+ Years/ Dye-Free Children's Allergy Loratadine Chewable Tablets USP, 5 mg Antihistamine Non-drowsy** Indoor and outdoor allergies 24-hour relief of sneezing, runny nose, itchy, watery eyes,itchy throat or nose up&up **When taken as directed. See drug facts panel. 30 CHEWABLE TABLETS THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING GRAPE FLAVOR ACTUAL SIZE 30 CHEWABLE TABLETS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information