Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: G;L;10 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2013-04-30

Medication Information

Purpose

Antihistamine

Description

Original Prescription Strength Non-Drowsy* Indoor and Outdoor Allergies *When taken as directed. See Drug Facts Panel. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Do Not Use

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

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 51079-246-20

Loratadine

Tablets, USP

10 mg

Antihistamine

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief(See Uses section of enclosed leaflet)

*When taken as directed. See enclosed leaflet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Other Information

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions Or Comments?

1-800-848-0462

Serious side effects associated with use of this product may be reported to this number.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

S-11333 R3

1/21

When Using This Product

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

Directions (24 Hour Relief)

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredient (in Each Tablet)

Loratadine USP, 10 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

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Purpose

Antihistamine

Do Not Use (Do not use)

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

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 51079-246-20

Loratadine

Tablets, USP

10 mg

Antihistamine

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief(See Uses section of enclosed leaflet)

*When taken as directed. See enclosed leaflet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions Or Comments? (Questions or comments?)

1-800-848-0462

Serious side effects associated with use of this product may be reported to this number.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

S-11333 R3

1/21

When Using This Product (When using this product)

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

Directions (24 Hour Relief)

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

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.

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.

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

ask a health professional before use

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

Loratadine USP, 10 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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "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", " ": "Original Prescription Strength Non-Drowsy* Indoor and Outdoor Allergies *When taken as directed. See Drug Facts Panel. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "Purpose": "Antihistamine", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", " ": "PRINCIPAL DISPLAY PANEL – 10 mg NDC 51079-246-20 Loratadine Tablets, USP 10 mg Antihistamine Original Prescription Strength Non-Drowsy* Indoor and Outdoor Allergies 24 Hour Relief (See Uses section of enclosed leaflet) *When taken as directed. See enclosed leaflet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "Other information": "TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] protect from excessive moisture", "Inactive Ingredients": "Corn starch, lactose monohydrate and magnesium stearate.", "Questions or comments?": "1-800-848-0462 Serious side effects associated with use of this product may be reported to this number. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11333 R3 1/21", "When using this product": "do not take more than directed. Taking more than directed may cause drowsiness.", "Directions (24 Hour Relief)": "adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding,": "ask a health professional before use", "Active Ingredient (in each tablet)": "Loratadine USP, 10 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information