Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine Hydrochloride USP 240 mg
Pseudoephedrine Hydrochloride Tablet, Extended Release
FDA Label NDC 58602-884
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Pseudoephedrine Hydrochloride (NDC 58602-884). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product do not exceed recommended dosage, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- reduces swelling of nasal passages
- relieves sinus 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
- had obstruction or narrowing of the bowel Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).
When Using This Product Do Not Exceed Recommended Dosage
Stop use and ask a doctor if
Otc - Stop Use
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- you experience persistent abdominal pain or vomiting
Otc - Pregnancy Or Breast Feeding
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
- store at 20° to 25°C (68° to 77°F).
- do not use if the individual blister unit is open or torn
- see side panel for lot number and expiration date
- FDA approved dissolution test specifications differ from USP.
Inactive Ingredients
black iron oxide, cellulose acetate, colloidal silicon dioxide, dibutyl sebacate, glyceryl mono and dicaprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
Questions or comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 2 X 5 Blister Carton Label
AUROHEALTH Ppackage Label-principal Display Panel (2 x 5 Blister Carton)
NDC 58602-884-58
#Compare to the active
ingredient in Sudafed® Sinus Congestion 24 Hour.
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP 240 mg
Nasal Decongestant
MAXIMUM STRENGTH
24
HOUR
• SINUS PRESSURE + CONGESTION
• NON-DROWSY
Actual Size
2 x 5 tablets per blister card 
* Please review the disclaimer below.
