Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg
Pseudoephedrine Hydrochloride Tablet
FDA Label NDC 0904-6727
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Pseudoephedrine Hydrochloride (NDC 0904-6727). 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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
- take every 4-6 hours
- do not take more than 4 doses in 24 hours
adults & children 12 years & over | 2 tablets |
children 6 to under 12 years | 1 tablets |
children under 6 years | do not use |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredient
calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar, titanium dioxide
Questions Or Comments?
(800) 616-2471
Other
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Sudafed®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA
Package Label.Principal Display Panel
MAJOR ®
NDC 0904-6727-60
Non Drowsy SudoGest TM
Nasal Decongestant
Pseudoephedrine Hydrochloride 30mg
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness
Compare to the active ingredient in Sudafed® Congestion*
100 Tablets
1004-100c-major (1004 100c)
* Please review the disclaimer below.
