Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CVS PHARMACY FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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
Route
ORAL
Applications
ANDA090818

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Purpose Fexofenadine HCl USP 60 mg Antihistamine Pseudoephedrine HCl USP 120 mg Nasal Decongestant
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium dibasic calcium phosphate dihydrate ethyl cellulose ferric oxide yellow hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol povidone stearic acid.
Strengths
60 mg 120 mg
Quantities
30 tablet
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes 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 Imprint: 724

Identifiers & Packaging

Container Type BOX
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton CVSHealth ® Compare to the active ingredients in Allegra-D ® * Indoor & Outdoor Allergies NDC 69842-973-30 Non-Drowsy ALLERGY & CONGESTION RELIEF Allergy Relief D FEXOFENADINE HCl 60 mg/Antihistamine PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant EXTENDED-RELEASE TABLETS, USP 12 HOUR 12 Hour Relief of: Nasal & sinus congestion due to colds or allergies Sneezing; Runny nose; Itchy, watery eyes & Itchy nose or throat due to allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 30 EXTENDED-RELEASE TABLETS Actual Size PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton CVSHealth ® Compare to the active ingredients in Allegra-D ® * Indoor & Outdoor Allergies NDC 69842-973-30 Non-Drowsy ALLERGY & CONGESTION RELIEF Allergy Relief D FEXOFENADINE HCl 60 mg/Antihistamine PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant EXTENDED-RELEASE TABLETS, USP 12 HOUR 12 Hour Relief of: Nasal & sinus congestion due to colds or allergies Sneezing; Runny nose; Itchy, watery eyes & Itchy nose or throat due to allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 30 EXTENDED-RELEASE TABLETS Actual Size PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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: runny nose sneezing itchy, watery eyes 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; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with 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. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) 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 you get nervous, dizzy, or sleepless 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 (1800-222-1222).
Purpose

Active ingredients (in each extended-release tablet) Purpose Fexofenadine HCl USP, 60 mg Antihistamine Pseudoephedrine HCl USP, 120 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. if you have difficulty swallowing

When Using

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions )

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 you get nervous, dizzy, or sleepless

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 (1800-222-1222).

Storage & Handling

Other information do not use if carton is opened or if individual blister units are torn or opened store between 20° to 25°C (68° to 77°F) Meets dissolution test 6

Questions

Questions or comments? Call toll-free 1-800-818-4555 weekdays


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