Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

SUDAFED (pseudoephedrine hydrochloride) Coated Tablets DESCRIPTION Drug Facts Active ingredient (in each tablet): Pseudoephedrine HCl 30 mg

INDICATIONS Nasal Decongestant Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies DOSAGE AND ADMINISTRATION Directions adults and children 12 years and over take 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age HOW SUPPLIED Other Information store between 20 - 25°C (68 - 77°F) do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date Inactive Ingredients carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, shellac, sodium starch glycolate, talc, titanium dioxide Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect) Pseudoephedrine HCl, Nasal Decongestant NDC 50580-545-24 SINUS PRESSURE + CONGESTION MAXIMUM STRENGTH 24 TABLETS - 30 mg EACH McNeil Consumer Healthcare Div. McNeil-PPC, Inc

PATIENT INFORMATION Do not use 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever 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. (1-800-222-1222)

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

SIDE EFFECTS No information provided. DRUG INTERACTIONS No information provided.

WARNINGS Do not use 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever 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. (1-800-222-1222) PRECAUTIONS No information provided.