Active Ingredient
Pseudoephedrine HCI, USP 120 mg
Pseudoephedrine Hydrochloride Tablet, Extended Release
FDA Label NDC 62011-0306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Pseudoephedrine Hydrochloride (NDC 62011-0306). 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 active ingredient, 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,, 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:
▪ common cold▪ hay fever▪ upper respiratory allergies▪ temporarily restores freer breathing through the nose▪ promotes nasal and/or sinus drainage▪ 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▪ diabetes▪ thyroid disease▪ 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
▪ symptoms do not get better within 7 days or occur with a fever▪ you get nervous, dizzy, or sleepless
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 older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours▪ children under 12 years: ask a doctor
Other Information
▪ store at 59° to 77° F in a dry place▪ protect from light▪ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide
Package/Label Principal Display Panel
NDC 62011-0306-1
Compare to Sudafed® 12 Hour active ingredient*
nasal decongestant
pseudoephedrine hydrochloride 120 mg extended-release tablets, USP
long-acting nasal decongestant
nasal & sinus congestion due to colds & allergies/sinus pressure
12 Hour non-drowsy maximum strength
10 coated capsule-shaped tablets 120 mg each
* Please review the disclaimer below.
