Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

Calcium Carbonate Silicon Dioxide Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Starch, Corn Propylene Glycol Shellac Sodium Alginate Talc Titanium Dioxide Microcrystalline Cellulose Povidone, Unspecified Sodium Citrate, Unspecified Form Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: RX724 Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2004-11-17 Until 2022-08-31

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

Directions

do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Questions?

call 1-800-406-7984

Keep the Carton. It contains important information.

See end panel for expiration date.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Other Information

sodium:contains 10 mg/tablet
calcium:contains 25 mg/tablet
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20 ^°C to 25 ^°C (68 ^°F to 77 ^°F)
protect from light and store in a dry place

Inactive Ingredients

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Principal Display Panel

NDC 51660-491-15

Original Prescription Strength

^*Compare to the active ingredients of Claritin-D ^® 24 Hour

NON-DROWSY ^**

Allergy Relief & Nasal Decongestant

24 Hour Allergy Relief

Loratadine, USP 15 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

Allergy & Congestion 15 Extended-Release Tablets

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

^* The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ^®24 HOUR is a registered trademark of Schering Corporation.

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

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 Ingredients (in Each Tablet)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Package Label. Principal Display Panel

NDC 51660-491-69

Original Prescription Strength

^*Compare to the active ingredients of Claritin-D ^® 24 Hour

NON-DROWSY ^**

Allergy Relief & Nasal Decongestant

24 Hour Allergy Relief

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

Allergy & Congestion 10 Extended-Release Tablets

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

^* The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ^®24 HOUR is a registered trademark of Schering Corporation.

When Using This Product Do Not Take More Than Directed.

Taking more than directed may cause drowsiness.

Structured Label Content

Uses (USES)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

Purpose (PURPOSE)

Antihistamine

Nasal decongestant

Directions (DIRECTIONS)

do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Questions? (QUESTIONS?)

call 1-800-406-7984

Keep the Carton. It contains important information.

See end panel for expiration date.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Other Information (OTHER INFORMATION)

sodium:contains 10 mg/tablet
calcium:contains 25 mg/tablet
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20 ^°C to 25 ^°C (68 ^°F to 77 ^°F)
protect from light and store in a dry place

Inactive Ingredients (INACTIVE INGREDIENTS)

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Principal Display Panel

NDC 51660-491-15

Original Prescription Strength

^*Compare to the active ingredients of Claritin-D ^® 24 Hour

NON-DROWSY ^**

Allergy Relief & Nasal Decongestant

24 Hour Allergy Relief

Loratadine, USP 15 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

Allergy & Congestion 15 Extended-Release Tablets

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

^* The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ^®24 HOUR is a registered trademark of Schering Corporation.

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.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

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 Ingredients (in Each Tablet) (ACTIVE INGREDIENTS (IN EACH TABLET))

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

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

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Package Label. Principal Display Panel (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL)

NDC 51660-491-69

Original Prescription Strength

^*Compare to the active ingredients of Claritin-D ^® 24 Hour

NON-DROWSY ^**

Allergy Relief & Nasal Decongestant

24 Hour Allergy Relief

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

Allergy & Congestion 10 Extended-Release Tablets

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

^* The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ^®24 HOUR is a registered trademark of Schering Corporation.

When Using This Product Do Not Take More Than Directed. (When using this product do not take more than directed.)

Taking more than directed may cause drowsiness.

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: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose", "PURPOSE": "Antihistamine Nasal decongestant", "DIRECTIONS": "do not divide, crush, chew or dissolve the tablet adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "QUESTIONS?": "call 1-800-406-7984 Keep the Carton. It contains important information. See end panel for expiration date. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902", "OTHER INFORMATION": "sodium: contains 10 mg/tablet calcium: contains 25 mg/tablet TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20 ° C to 25 ° C (68 ° F to 77 ° F) protect from light and store in a dry place", "INACTIVE INGREDIENTS": "calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide", "Principal Display Panel": "NDC 51660-491-15 Original Prescription Strength * Compare to the active ingredients of Claritin-D ® 24 Hour NON-DROWSY ** Allergy Relief & Nasal Decongestant 24 Hour Allergy Relief Loratadine, USP 15 mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Indoor & Outdoor Allergies Relief of: Nasal & Sinus Congestion Due to Colds or Allergies Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Due to Allergies Allergy & Congestion 15 Extended-Release Tablets ** When taken as directed. See Drug Facts Panel. * The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ® 24 HOUR is a registered trademark of Schering Corporation.", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs", "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 INGREDIENTS (IN EACH TABLET)": "Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg", "Ask a doctor before use if you have": "heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.", "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL": "NDC 51660-491-69 Original Prescription Strength * Compare to the active ingredients of Claritin-D ® 24 Hour NON-DROWSY ** Allergy Relief & Nasal Decongestant 24 Hour Allergy Relief Loratadine, USP 10 mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Indoor & Outdoor Allergies Relief of: Nasal & Sinus Congestion Due to Colds or Allergies Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Due to Allergies Allergy & Congestion 10 Extended-Release Tablets ** When taken as directed. See Drug Facts Panel. * The product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN-D ® 24 HOUR is a registered trademark of Schering Corporation.", "When using this product do not take more than directed.": "Taking more than directed may cause drowsiness."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information