FDA Label for Sudogest
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sudogest Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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 (In Each Tablet)
Pseudoephedrine HCl 30 mg
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
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 2 for 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• diabetes• thyroid disease• high blood pressure• trouble urinating due to an enlarged prostate gland
When Using This Product
do not exceed recommended dose.
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occur• symptoms do not improve within 7 days or occur with fever
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.
Directions
adults and | take 2 tablets every 4 to |
children ages | take 1 tablet every 4 to 6 |
children under | do not use this product |
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 Ingredients
croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin
Questions Or Comments?
(800) 616-2471
Principal Display Panel
NDC 7105-133-24
*Compare to the active ingredient in Sudafed® Congestion
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
Non-Drowsy
SudoGest™
NASAL DECONGESTANT
Pseudoephedrine Hydrochloride 30 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness
24 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
50844 REV0712L11212
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Rev. 08/13
Re-Order No. 700321
Relabeled By;
Proficient Rx LP
Thousand Oaks CA 91320
* Please review the disclaimer below.