Sudafed

What is Sudafed and how is it used?

Sudafed is a prescription medicine used to treat the symptoms of nasal congestion or sinus congestion. Sudafed may be used alone or with other medications.

Sudafed belongs to a class of drugs called Decongestants, Systemic.

It is not known if Sudafed is safe and effective in children younger than 2 years of age.

What are the possible side effects of Sudafed?

Sudafed may cause serious side effects including:

• fast or pounding heartbeats,
• severe dizziness,
• severe nervousness, and
• sleep problems (insomnia)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Sudafed include:

• feeling restless or nervous

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sudafed. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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.

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

CLINICAL PHARMACOLOGY

No information provided.

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)