FDA Label for Topcare Nasal Decongestant Pe
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Topcare Nasal Decongestant Pe Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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
Questions Or Comments?
1-888-423-0139
Principal Display Panel
COMPARE TO SUDAFED PE® CONGESTION
ACTIVE INGREDIENT
NON-DROWSY
Nasal Decongestant PE
PHENYLEPHRINE HCl TABLETS, 10 mg
MAXIMUM STRENGTH
OUR PHARMACISTS RECOMMEND
Sinus + Nasal Congestion
Sinus Pressure
actual size
72 TABLETS
* Please review the disclaimer below.