allergy congestion relief LORATADINE PSEUDOEPHEDRINE SULFATE KROGER 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
ANDA075989
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Loratadine 10 mg Pseudoephedrine sulfate 240 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide ferric oxide hydrogenated vegetable oil hypromellose magnesium stearate polyethylene glycol polyethylene oxide propylene glycol 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 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: oval Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
7AJO3BO7QN Y9DL7QPE6B
Packaging

Package/Label Principal Display Panel COMPARE TO the active ingredients of CLARITIN-D ® 24 HOUR See bottom panel Kroger ® OUR PHARMACIST RECOMMENDED Non-Drowsy* Allergy & Congestion Relief ACTUAL SIZE RELIEF OF: Nasal & Sinus Congestion Due to Colds or Allergies; Pseudoephedrine Sulfate 240 mg Nasal Decongestant Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies Loratadine 10 mg Antihistamine Extended Release Tablets INDOOR & OUTDOOR ALLERGIES 24 HOUR 15 EXTENDED-RELEASE TABLETS *When taken as directed. See Drug Facts Panel. 2d8-45-allergy-and-congestion-relief

Package Descriptions
  • Package/Label Principal Display Panel COMPARE TO the active ingredients of CLARITIN-D ® 24 HOUR See bottom panel Kroger ® OUR PHARMACIST RECOMMENDED Non-Drowsy* Allergy & Congestion Relief ACTUAL SIZE RELIEF OF: Nasal & Sinus Congestion Due to Colds or Allergies; Pseudoephedrine Sulfate 240 mg Nasal Decongestant Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies Loratadine 10 mg Antihistamine Extended Release Tablets INDOOR & OUTDOOR ALLERGIES 24 HOUR 15 EXTENDED-RELEASE TABLETS *When taken as directed. See Drug Facts Panel. 2d8-45-allergy-and-congestion-relief

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 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 or comments? 1-800-632-6900


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