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
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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 |
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| children ages 6 to 11 years |
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| children under 6 years |
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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
SLIDESHOW
Could I Be Allergic? Discover Your Allergy Triggers See SlideshowWARNINGS
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.
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)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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