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 Major Pharmaceuticals. 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.
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 60 mg
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
Package Label.Principal Display Panel
MAJOR
NDC 0904-6728-52
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
SudoGest
TM
Nasal Decongestant 60mg
Pseudoephedrine Hydrochloride 60 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness
100 Tablets
* Please review the disclaimer below.