Allergy and Congestion Relief LORATADINE PSEUDOEPHEDRINE SULFATE L. PERRIGO COMPANY 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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose
FunFoxMeds box
Substance Loratadine
Route
ORAL
Applications
ANDA076050

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg
Inactive Ingredients
Inactive ingredients croscarmellose sodium dibasic calcium phosphate hypromellose lactose monohydrate magnesium stearate pharmaceutical ink povidone titanium dioxide
Strengths
5 mg 120 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 Temporarily Relieves Nasal Congestion Due To The Common Cold Hay Fever Or Other Upper Respiratory Allergies Reduces Swelling Of Nasal Passages Temporarily Relieves Sinus Congestion And Pressure Temporarily Restores Freer Breathing Through The Nose
Pill Appearance
Shape: round Color: white Imprint: 7U0

Identifiers & Packaging

Container Type UNKNOWN
UNII
7AJO3BO7QN Y9DL7QPE6B
Packaging

Package/Label Principal Display Panel Compare to Claritin-D ® 12 hour Extended Release Tablets active ingredients allergy & congestion relief Pseudoephedrine Sulfate 120 mg/Loratadine 5 mg Extended Release Tablets Nasal Decongestant/Antihistamine 12 Hour 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* *When taken as directed. See Drug Facts Panel. Actual Size 20 EXTENDED RELEASE TABLETS allergy and congestion relief image

Package Descriptions
  • Package/Label Principal Display Panel Compare to Claritin-D ® 12 hour Extended Release Tablets active ingredients allergy & congestion relief Pseudoephedrine Sulfate 120 mg/Loratadine 5 mg Extended Release Tablets Nasal Decongestant/Antihistamine 12 Hour 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* *When taken as directed. See Drug Facts Panel. Actual Size 20 EXTENDED RELEASE TABLETS allergy and congestion relief image

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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • 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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • 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 every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings & Precautions
Warnings
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 or comments? 1-800-719-9260


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