FDA Label for Pseudoephedrine Hydrochloride
View Indications, Usage & Precautions
Pseudoephedrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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
Pseudoephedrine HCI, USP 120 mg
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.