Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2004-11-17

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 McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

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. (for blister cartons only)
•
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

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.

When Using This Product Do Not Take More Than Directed.

Taking more than directed may cause drowsiness.

Principal Display Panel 240 Mg/10 Mg Tablet Blister Pack Carton

sunmark ^®

COMPARE TO CLARITIN-D ^® 24 HOUR

TABLETS ACTIVE INGREDIENTS ^**

NDC 49348-543-57

24 HOUR

Original Prescription Strength

allergy & congestion

lorata•dine D

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Extended-Release Tablets

Indoor & Outdoor Allergies

Relief of Nasal and Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose Due to Allergies

NON-DROWSY ^*

15 Extended-Release Tablets

^* When taken

as directed.

See Drug

Facts Panel.

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 McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

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. (for blister cartons only)
•
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

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.

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.

Principal Display Panel 240 Mg/10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton)

sunmark ^®

COMPARE TO CLARITIN-D ^® 24 HOUR

TABLETS ACTIVE INGREDIENTS ^**

NDC 49348-543-57

24 HOUR

Original Prescription Strength

allergy & congestion

lorata•dine D

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Extended-Release Tablets

Indoor & Outdoor Allergies

Relief of Nasal and Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose Due to Allergies

NON-DROWSY ^*

15 Extended-Release Tablets

^* When taken

as directed.

See Drug

Facts Panel.

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 McKesson One Post Street, San Francisco, CA 94104 www.sunmarkbrand.com", "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. (for blister cartons only) • 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", "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.", "When using this product do not take more than directed.": "Taking more than directed may cause drowsiness.", "PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton": "sunmark ® COMPARE TO CLARITIN-D ® 24 HOUR TABLETS ACTIVE INGREDIENTS ** NDC 49348-543-57 24 HOUR Original Prescription Strength allergy & congestion lorata•dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended-Release Tablets Indoor & Outdoor Allergies Relief of Nasal and Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies NON-DROWSY * 15 Extended-Release Tablets * When taken as directed. See Drug Facts Panel."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information