Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Label information

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP, 120 mg

Antihistamine

Nasal decongestant

• 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

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 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.

• do not divide, crush, chew or dissolve the tablet; swallow tablet whole

• safety sealed: 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) store between 20° to 25°C (68° to 77°F)
• FDA approved dissolution test specifications differ from USP.
• FDA approved organic impurities test procedure differs from USP Procedure 1.

colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

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[Image in the official label — see DailyMed source]