Fexofenadine HCl and Pseudoephedrine HCl (fexofenadine hcl 180 mg pseudoephedrine 240 mg) Dailymed

Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 mg

Purpose

Antihistamine

Nasal decongestant

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 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

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.

Directions

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

adults and children 12 years of age and over Â	take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet 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

• each tablet contains: 28 mg sodium
• safety sealed: do not use if carton is opened or if individual buler units are torn or opened
• store between 20° - 25°C (68° - 77°F)
• FDA approved dissolution test specifications differ from USP

Inactive Ingredients

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

Questions?

Questions? Call 1-888-375-3784 Weekdays (9am - 8pm EST)

Distributed by:

RUGBY LABORATORIES.

Indianapolis, IN 46268

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