SUDAFED PE CONGESTION- phenylephrine hydrochloride tablet
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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.
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Active ingredient (in each tablet)
Phenylephrine HCl 10 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 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
|
| children under 12 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
-
do not use if carton or blister unit is opened or broken
Inactive ingredients
carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions or comments?
call
1-888-217-2117 (toll-free) or
215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
SINUS
NDC 50580-546-50
SUDAFED
PE®
CONGESTION
Phenylephrine HCl Tablets
Nasal Decongestant
SINUS + NASAL
CONGESTION
SINUS PRESSURE
18 TABLETS
10 mg EACH
MAXIMUM
STRENGTH
FORMERLY NAMED
SUDAFED PE
® Nasal Decongestant
1 Pill/Dose
‡ Actual Pill Size
NON-DROWSY
