Fexofenadine HCl and Pseudoephedrine HCI FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI HEB FDA Approved Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
FunFoxMeds box
Route
ORAL
Applications
ANDA076667
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(s) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium colloidal silicon dioxide ferric oxide hypromellose kollidon SR magnesium stearate mannitol powder cellulose and triethyl citrate.
Strengths
60 mg 120 mg
Treats Conditions
Use S Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Nasal Congestion Itchy Watery Eyes Itching Of The Nose Or Throat 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: R;195

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

Principal Display Panel Blister carton 30's (6x5 unit-dose)

Package Descriptions
  • Principal Display Panel Blister carton 30's (6x5 unit-dose)

Overview

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Indications & Usage

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat 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) the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions). Stop use and ask 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 Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contacta Poison Control Center right away.
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. 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 takeas directed (see Directions).

Stop Use & Ask a Doctor

Stop use and ask 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 contacta Poison Control Center right away.

Storage & Handling

Storage store between 20° to 25°C (68° to 77°F)

Questions

Questions or comments? call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA


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