FDA Label for Nasal Decongestant Pe
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Nasal Decongestant Pe Product Label
The following document was submitted to the FDA by the labeler of this product Valu Merchandisers Company. 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.
Other
Drug Facts
Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
- temporarily relieves sinus congestion and pressure
Otc - Do Not Use
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 use more than directed
Stop Use And Ask A Doctor If
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
- children under 12 years of age: ask a doctor
Other Information
- store at 15°-25°C (59°-77°F) in a dry place
- retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN SUDAFED PE® CONGESTION†
Best Choice®
Non-Drowsy
MAXIMUM STRENGTH
NASAL DECONGESTANT PE
Actual Size
Phenylephrine HCl
For Relief of:
• Sinus Pressure
• Congestion
18 TABLETS
10 mg EACH
* Please review the disclaimer below.