Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60 mg/120 mg

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet) Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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 doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

safety sealed; do not use if inner safety seal is open or torn store between 20° to 25°C (68° to 77°F) Meets dissolution test 6

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

Questions?

SPL UNCLASSIFIED SECTION

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-724-83 ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP 60 mg/120 mg ALLERGY & CONGESTION 12 HR Antihistamine/Nasal Decongestant Indoor and Outdoor Allergies 30 Tablets SUN PHARMA

Principal Display Panel-Showbox

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-724-94 ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY Fexofenadine HCI and Pseudoephedrine HCI Extended-Release Tablets, USP 60 mg/120 mg ALLERGY & CONGESTION 12 HR Antihistamine/Nasal Decongestant 10 Extended-Release Tablets INDOOR / OUTDOOR RELIEF OF • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN SUN PHARMA