Loratadine and Pseudoephedrine Sulfate LORATADINE AND PSEUDOEPHEDRINE SULFATE SAFEWAY 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) Purpose Loratadine USP 10 mg Antihistamine Pseudoephedrine sulfate USP 240 mg Nasal decongestant
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
Quantities
10 tablet
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

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton NDC 21130-724-69 Signature care™ Quality Guaranteed 24 HOUR | ORIGINAL PRESCRIPTION STRENGTH Allergy Relief & Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/ Nasal Decongestant Actual Size Compare to Claritin-D ® 24 Hour active ingredients † • Indoor & outdoor allergies • Non-drowsy* • Relief of: Nasal & sinus congestion due to colds or allergies Sneezing; runny nose; itchy,watery eyes; itchy throat or nose due to allergies *When taken as directed. See Drug Facts Panel. 10 EXTENDED-RELEASE TABLETS PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton NDC 21130-724-69 Signature care™ Quality Guaranteed 24 HOUR | ORIGINAL PRESCRIPTION STRENGTH Allergy Relief & Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/ Nasal Decongestant Actual Size Compare to Claritin-D ® 24 Hour active ingredients † • Indoor & outdoor allergies • Non-drowsy* • Relief of: Nasal & sinus congestion due to colds or allergies Sneezing; runny nose; itchy,watery eyes; itchy throat or nose due to allergies *When taken as directed. See Drug Facts Panel. 10 EXTENDED-RELEASE TABLETS PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack 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

Active ingredients (in each tablet) Purpose Loratadine, USP 10 mg Antihistamine Pseudoephedrine sulfate, USP 240 mg 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).

Storage & Handling

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

Questions

Questions? call 1-888-723-3929


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