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

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Drug Facts

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

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

do not use if carton is opened or if individual blister units are torn or opened 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 or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-818-4555 weekdays

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Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

† Compare To the active ingredients of Allegra-D ® NDC 51660-037-21 ohm ® NON-DROWSY Original Prescription Strength Fexofenadine HCl 60 mg/Antihistamine Pseudoephedrine HCl 120 mg/Nasal Decongestant Extended-Release Tablets, USP Allergy & Congestion Indoor and Outdoor Allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 12 Hour 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 20 Extended-Release Tablets