Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

Calcium Carbonate Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Sodium Alginate Sodium Citrate, Unspecified Form Talc Titanium Dioxide Ferrosoferric Oxide 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

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

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

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

ohm ^®

NDC 63187-305-10

NON-DROWSY ^*

24 Hour Allergy Relief

Original Prescription Strength

Allergy Relief & Nasal Decongestant

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

5 Extended-Release Tablets

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

Distributed by: Ohm Laboratories Inc.

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

5079399/R0610

5’s blister carton

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.

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

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 (PRINCIPAL DISPLAY PANEL)

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

ohm ^®

NDC 63187-305-10

NON-DROWSY ^*

24 Hour Allergy Relief

Original Prescription Strength

Allergy Relief & Nasal Decongestant

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

5 Extended-Release Tablets

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

Distributed by: Ohm Laboratories Inc.

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

5079399/R0610

5’s blister carton

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.

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", "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": "† Compare to the active ingredients of Claritin-D ® 24 Hour ohm ® NDC 63187-305-10 NON-DROWSY * 24 Hour Allergy Relief Original Prescription Strength Allergy Relief & Nasal Decongestant 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 5 Extended-Release Tablets * When taken as directed. See Drug Facts Panel. Distributed by: Ohm Laboratories Inc. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 5079399/R0610 5’s blister carton 5’s blister carton", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information