Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 60 mg
Pseudoephedrine Hydrochloride Tablet
FDA Label NDC 50090-4546
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Pseudoephedrine Hydrochloride (NDC 50090-4546). 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, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - when using, 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
Otc - Purpose
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
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product do not exceed recommended dose.
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.
Questions Or Comments?
(800) 616-2471
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
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