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 30 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
- 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
* Please review the disclaimer below.