SUDAFED- pseudoephedrine hydrochloride tablet, coated
McNeil Consumer Healthcare Div. McNeil-PPC, Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg
Purpose
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
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)
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
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
