Meijer Distribution, Inc. 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 Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2019-08-27

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

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.

Package/label Principal Display Panel

meijer_®

COMPARE TO CHILDREN’S CLARITIN^®CHEWABLES ACTIVE INGREDIENT

NON-DROWSY* | CHILDREN’S

allergy relief

Loratadine Chewable Tablets, 5 mg Antihistamine

Indoor & Outdoor Allergies

24 HOUR

NON-DROWSY* RELIEF OF: SNEEZING; RUNNY NOSE; ITCHY, WATERY EYES; ITCHY THROAT OR NOSE

GRAPE FLAVOR

30 CHEWABLE TABLETS

Ages 2 years and older

*When taken as directed. See Drug Facts Panel.

Actual Size

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

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

meijer_®

COMPARE TO CHILDREN’S CLARITIN^®CHEWABLES ACTIVE INGREDIENT

NON-DROWSY* | CHILDREN’S

allergy relief

Loratadine Chewable Tablets, 5 mg Antihistamine

Indoor & Outdoor Allergies

24 HOUR

NON-DROWSY* RELIEF OF: SNEEZING; RUNNY NOSE; ITCHY, WATERY EYES; ITCHY THROAT OR NOSE

GRAPE FLAVOR

30 CHEWABLE TABLETS

Ages 2 years and older

*When taken as directed. See Drug Facts Panel.

Actual Size

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", "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", "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.", "Package/Label Principal Display Panel": "meijer ® COMPARE TO CHILDREN’S CLARITIN ® CHEWABLES ACTIVE INGREDIENT NON-DROWSY* | CHILDREN’S allergy relief Loratadine Chewable Tablets, 5 mg Antihistamine Indoor & Outdoor Allergies 24 HOUR NON-DROWSY* RELIEF OF: SNEEZING; RUNNY NOSE; ITCHY, WATERY EYES; ITCHY THROAT OR NOSE GRAPE FLAVOR 30 CHEWABLE TABLETS Ages 2 years and older *When taken as directed. See Drug Facts Panel. Actual Size"}

Meijer Distribution, Inc. 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