FDA Label for Nasal Decongestant Pe Non Drowsy
View Indications, Usage & Precautions
Nasal Decongestant Pe Non Drowsy Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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 dosage
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 |
|
children under 12 years | ask a doctor |
Other Information
• store at 20-25°C (68-77°F)• do not use if blister unit is broken or torn
Inactive Ingredients
anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Principal Display Panel
NON-DROWSY
nasal decongestant PE
PHENYLEPHRINE HCl TABLETS, 10mg
nasal & sinus congestion
sinus pressure
MAXIMUM STRENGTH
ASPIRIN-FREE
ONE TABLET DOSE
72 TABLETS
ACTUAL SIZE
Compare to the Active Ingredient in Sudafed PE® Congestion
* Please review the disclaimer below.