FDA Label for Pseudoephedrine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- 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
Pseudoephedrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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)
Pseudoephedrine HCl 120 mg
Purpose
Nasal decongestant
Uses
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies• temporarily relieves sinus congestion and pressure
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 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 | do not use this product in children under 12 years of age |
Other Information
• each tablet contains: calcium 45 mg• store at 20 - 25°C (68 - 77°F) in a dry place• protect from light• do not use if blister unit is broken or torn• see carton end panel for lot number and expiration date• this product meets the requirements of USP Drug Release Test 3
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Compare to Sudafed® 12 Hour active ingredient
Pseudoephedrine Hydrochloride Extended Release Tablets 120 mg
Long-Acting Nasal Decongestant
Maximum Strength – Non-Drowsy
Sinus Pressure – Congestion
10 Coated Caplets*
120 mg EACH
*(Capsule-shaped Tablets)
actual size
Pseudoephedrine HCl – Sinus
12 Hour
* Please review the disclaimer below.