FDA Label for Pseudoephedrine Hcl
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 MG, BLISTER CARTON 20 (2 X 10) EXTENDED-RELEASE TABLETS
Pseudoephedrine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth 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)
Pseudoephedrine HCl USP 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
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
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 36 mg
- store at 20° to 25°C (68° to 77°F). Protect from light.
- do not use if the individual blister unit is open or torn
- see side panel for lot number and expiration date
- USP Dissolution Test pending
Inactive Ingredients
colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.
Questions Or Comments?
call 1-855-274-4122
Package Label-Principal Display Panel - 120 Mg, Blister Carton 20 (2 X 10) Extended-Release Tablets
AUROHEALTH
NDC 58602-804-67
MAXIMUM STRENGTH
Pseudoephedrine HCl
Extended-Release Tablets USP
120 mg
Long-Acting Nasal Decongestant
SINUS PRESSURE+CONGESTION
NON-DROWSY
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS
12 HOUR
* Please review the disclaimer below.
