Description: Sudafed 12 Hour is a long-acting nasal decongestant providing temporary relief of nasal and sinus congestion due to a cold, allergy, or sinusitis for up to 12 hours. Sudafed 12 Hour helps clear nasal congestion and release sinus pressure to restore freer breathing without drowsiness.

Active Ingredient: Each coated extended-release tablet contains Pseudoephedrine Hydrochloride 120 mg.

Inactive Ingredients: Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, and Titanium Dioxide. Printed with edible blue ink. May also contain Carnauba Wax or Candelilla Wax.

Indications: For the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis. Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure. Temporarily restores freer breathing through the nose.

Directions: Adults and children 12 years and over--One tablet every 12 hours, not to exceed two tablets in 24 hours. Sudafed 12 Hour is not recommended for children under 12 years of age.

Warnings: Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Drug Interaction Precaution: Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

How Supplied: Boxes of 10 and 20.

Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.