Loratadine and Pseudoephedrine LORATADINE AND PSEUDOEPHEDRINE OHM LABORATORIES INC. FDA Approved 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
FunFoxMeds box
Substance Loratadine
Route
ORAL
Applications
ANDA076557

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine USP 10 mg Pseudoephedrine sulfate USP 240 mg
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
Strengths
10 mg 240 mg
Treats Conditions
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
Pill Appearance
Shape: capsule Color: white Imprint: RX724

Identifiers & Packaging

Container Type BOX
UNII
7AJO3BO7QN Y9DL7QPE6B
Packaging

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. 10s-blister-carton; 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. 15s-blister-carton

Package Descriptions
  • 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. 10s-blister-carton
  • 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. 15s-blister-carton

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
WARNINGS 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. 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. 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).
Purpose

PURPOSE Antihistamine Nasal decongestant

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.

When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use & Ask a Doctor

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

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).

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


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