SUDAFED
(pseudoephedrine hydrochloride) Coated Tablets
DESCRIPTION
Drug Facts
Active ingredient (in each tablet): Pseudoephedrine HCl 30 mg
For Consumers
What are the possible side effects of pseudoephedrine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using pseudoephedrine and call your doctor at once if you have:
- fast or pounding heartbeats;
- severe dizziness;
- severe nervousness; or
- sleep problems (insomnia).
Common side effects may include:
- feeling restless or nervous.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...
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 |
|
|
|
| children ages 6 to 11 years |
|
| children under 6 years |
|
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
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.
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)
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.
