Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Starch, Corn Starch, Pregelatinized Corn

Identifiers & Packaging

Pill Appearance

Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2003-08-19

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10 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

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

Do Not Use

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

Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

1800-325-1397

Other Information

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
store between 20 and 25° C (68 and 77° F)
protect from excessive moisture

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

The Medicine Shoppe ^®

NDC 49614-170-75

Non-Drowsy ^*

Original Prescription Strength

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

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

90 TABLETS

Compare to Claritin ^® active ingredient ^†

^† This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin ^® .

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.

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 (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 (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

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

Do Not Use (Do not use)

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

Questions? (QUESTIONS?)

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

1800-325-1397

Other Information (OTHER INFORMATION)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
store between 20 and 25° C (68 and 77° F)
protect from excessive moisture

Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

The Medicine Shoppe ^®

NDC 49614-170-75

Non-Drowsy ^*

Original Prescription Strength

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

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

90 TABLETS

Compare to Claritin ^® active ingredient ^†

^† This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin ^® .

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.

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": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "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": "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "QUESTIONS?": "call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date. Distributed by Medicine Shoppe International, Inc. Earth City, MO 63045 www.medicineshoppe.com 1800-325-1397", "OTHER INFORMATION": "TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20 and 25° C (68 and 77° F) protect from excessive moisture", "INACTIVE INGREDIENTS": "corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "PRINCIPAL DISPLAY PANEL": "The Medicine Shoppe ® NDC 49614-170-75 Non-Drowsy * Original Prescription Strength Loratadine Tablets USP, 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Allergy Relief Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. 90 TABLETS Compare to Claritin ® active ingredient † † This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin ® .", "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.", "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