American Sales Company Children’s Allergy Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Aspartame Silicon Dioxide D&c Red No. 27 Fd&c Blue No. 2 Magnesium Stearate Mannitol Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: L3Y8 Shape: round Color: purple Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2019-07-16

Medication Information

Purpose

Antihistamine

Description

Loratadine 5 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Other Information

•
phenylketonurics: contains phenylalanine 1.4 mg per tablet
•
do not use if blister unit is broken or torn
•
store between 20^° to 25^°C (68^° to 77^°F)

Inactive Ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Children’s Claritin^® Chewables

For Ages 2 and Older

Children’s Allergy Relief

Loratadine Chewable Tablets, 5mg

Actual Size

Antihistamine

20 CHEWABLE TABLETS

24hr

Non-Drowsy*

24 HOUR RELIEF OF:

Sneezing - Runny Nose - Itchy, Watery Eyes

Itchy Throat Or Nose

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

OUR PHARMACISTS RECOMMEND

GRAPE FLAVOR

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 use.

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 5 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

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

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)

•
phenylketonurics: contains phenylalanine 1.4 mg per tablet
•
do not use if blister unit is broken or torn
•
store between 20^° to 25^°C (68^° to 77^°F)

Inactive Ingredients (Inactive ingredients)

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Children’s Claritin^® Chewables

For Ages 2 and Older

Children’s Allergy Relief

Loratadine Chewable Tablets, 5mg

Actual Size

Antihistamine

20 CHEWABLE TABLETS

24hr

Non-Drowsy*

24 HOUR RELIEF OF:

Sneezing - Runny Nose - Itchy, Watery Eyes

Itchy Throat Or Nose

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

OUR PHARMACISTS RECOMMEND

GRAPE FLAVOR

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

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": "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": ""}]

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", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients", "Other information": "• phenylketonurics: contains phenylalanine 1.4 mg per tablet • do not use if blister unit is broken or torn • store between 20 ° to 25 ° C (68 ° to 77 ° F)", "Inactive ingredients": "artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid", "Questions or comments?": "1-800-719-9260", "Principal Display Panel": "Compare to the active ingredient in Children’s Claritin ® Chewables For Ages 2 and Older Children’s Allergy Relief Loratadine Chewable Tablets, 5mg Actual Size Antihistamine 20 CHEWABLE TABLETS 24hr Non-Drowsy* 24 HOUR RELIEF OF: Sneezing - Runny Nose - Itchy, Watery Eyes Itchy Throat Or Nose Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. OUR PHARMACISTS RECOMMEND GRAPE FLAVOR", "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 use.", "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 5 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose."}

American Sales Company Children’s Allergy Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information