Allegra-D Allergy and Congestion FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CHATTEM, 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
NDA020786

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Fexofenadine HCl 60 mg Active ingredients (in each tablet) Pseudoephedrine HCl 120 mg
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol pregelatinized starch stearic acid
Strengths
60 mg 120 mg
Quantities
30 tablets
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: 06;012D

Identifiers & Packaging

Container Type UNKNOWN
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL NDC 41167-4310-6 Allegra-D ® Allergy & Congestion 12HR fexofenadine HCl 60 mg/antihistamine pseudoephedrine HCl 120 mg/nasal decongestant Extended Release Tablets 30 Tablets NDC 41167-4310-6 Allegra-D® Allergy & Congestion 12HR fexofenadine HCI 60 mg/antihistamine pseudoephedrine HCI 120 mg/nasal decongestant Extended Release Tablets 30 Tablets

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 41167-4310-6 Allegra-D ® Allergy & Congestion 12HR fexofenadine HCl 60 mg/antihistamine pseudoephedrine HCl 120 mg/nasal decongestant Extended Release Tablets 30 Tablets NDC 41167-4310-6 Allegra-D® Allergy & Congestion 12HR fexofenadine HCI 60 mg/antihistamine pseudoephedrine HCI 120 mg/nasal decongestant Extended Release Tablets 30 Tablets

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 tablet 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 ) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (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.
Purpose

Purpose Antihistamine Purpose 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 ) 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

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.

Questions

Questions or comments? call toll-free 1-800-633-1610 or www.allegra.com


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