PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Blister carton
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient(s) Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP,120 mg
INDICATIONS & USAGE SECTION.
Use(s) 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 relives 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 SECTION.
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
SPL UNCLASSIFIED SECTION.
Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20 to 25C (68 to 77F) store between 20 to 25C (68 to 77F) this product meets the requirements of USP dissolution test 3.
INACTIVE INGREDIENT SECTION.
Inactive ingredients corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.
OTC - QUESTIONS SECTION.
Questions? Call 1-888-375-3784 Distributed by: Dr. Reddys Laboratories, Inc. Princeton, NJ 08540 Made in India
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 Parkinsons 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 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.
OTC - PURPOSE SECTION.
Purpose Antihistamine Nasal decongestant