Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CVS PHARMACY, INC. 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
ANDA209116

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium ferric oxide yellow hydroxypropyl cellulose hypromellose lactose monohydrate microcrystalline cellulose polyethylene glycol pregelatinized starch (maize) stearic acid Questions or Comments? call 1-855-274-4122 Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket RI 02895 © 2024 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
Strengths
60 mg 120 mg
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: capsule Color: yellow Imprint: Z;79

Identifiers & Packaging

Container Type BOX
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton CVSHealth ® Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion Tablets* NDC 51316-007-67 Non-Drowsy ALLERGY & CONGESTION RELIRF Allergy Relief D Fexofenadine HCl 60 mg/Antihistamine PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant EXTENDED-RELEASE TABLETS, USP 12 HOUR INDOOR/OUTDOOR RELIEF OF: • Nasal & sinus congestion due to colds or allergies • Sneezing; Runny nose; Itchy, watery eyes & Itchy nose or throat due to allergies 20 EXTENDED-RELEASE TABLETS Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 Blister Carton

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton CVSHealth ® Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion Tablets* NDC 51316-007-67 Non-Drowsy ALLERGY & CONGESTION RELIRF Allergy Relief D Fexofenadine HCl 60 mg/Antihistamine PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant EXTENDED-RELEASE TABLETS, USP 12 HOUR INDOOR/OUTDOOR RELIEF OF: • Nasal & sinus congestion due to colds or allergies • Sneezing; Runny nose; Itchy, watery eyes & Itchy nose or throat due to allergies 20 EXTENDED-RELEASE TABLETS Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 Blister 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 Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened. store at 20-25°C (68-77°F). Meets USP dissolution test 7

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
Purpose

Purpose Antihistamine Nasal decongestant

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 ) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (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 If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) right away.


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