Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Aspartame Croscarmellose Sodium Magnesium Stearate Mannitol Sodium Stearyl Fumarate

Identifiers & Packaging

Pill Appearance

Imprint: RC17 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2007-08-31

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

•
place 1 tablet on tongue; tablet disintegrates, with or without water

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

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

Other Information

•
Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
•
keep in a dry place.
•
use tablet immediately after opening individual blister.

Inactive Ingredients

aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Principal Display Panel

Premier Value ^®

NDC 68016-527-31

Original Prescription Strength

NON-DROWSY ^*

24 Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Allergy Relief

Antihistamine

Indoor & Outdoor Allergies

No water needed. Melts in your mouth.

Relief of:

•
Sneezing
•
Itchy, Watery Eyes
•
Runny Nose
•
Itchy Throat or Nose

For Adults and Children six years and older!

30 ORALLY DISINTEGRATING TABLETS

COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ^® REDITABS ^®†

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

^† This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ^® and REDITABS ^® are registered trademarks of Schering Corporation.

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, 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)

•
place 1 tablet on tongue; tablet disintegrates, with or without water

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

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

Other Information (OTHER INFORMATION)

•
Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
•
keep in a dry place.
•
use tablet immediately after opening individual blister.

Inactive Ingredients (INACTIVE INGREDIENTS)

aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value ^®

NDC 68016-527-31

Original Prescription Strength

NON-DROWSY ^*

24 Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Allergy Relief

Antihistamine

Indoor & Outdoor Allergies

No water needed. Melts in your mouth.

Relief of:

•
Sneezing
•
Itchy, Watery Eyes
•
Runny Nose
•
Itchy Throat or Nose

For Adults and Children six years and older!

30 ORALLY DISINTEGRATING TABLETS

COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ^® REDITABS ^®†

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

^† This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ^® and REDITABS ^® are registered trademarks of Schering Corporation.

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, 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": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": "SODIUM STEARYL FUMARATE", "unii": "7CV7WJK4UI", "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": "• place 1 tablet on tongue; tablet disintegrates, with or without water 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 CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431", "OTHER INFORMATION": "• Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture. • keep in a dry place. • use tablet immediately after opening individual blister.", "INACTIVE INGREDIENTS": "aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate", "PRINCIPAL DISPLAY PANEL": "Premier Value ® NDC 68016-527-31 Original Prescription Strength NON-DROWSY * 24 Hour Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg Allergy Relief Antihistamine Indoor & Outdoor Allergies No water needed. Melts in your mouth. Relief of: • Sneezing • Itchy, Watery Eyes • Runny Nose • Itchy Throat or Nose For Adults and Children six years and older! 30 ORALLY DISINTEGRATING TABLETS COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ® REDITABS ®† * When taken as directed. See Drug Facts Panel. † This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ® and REDITABS ® are registered trademarks of Schering Corporation.", "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, 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