Package Insert and Label Information: SudoGest
SUDOGEST- pseudoephedrine hydrochloride tablet
Rebel Distributors Corp
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
DRUG FACTS
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, and nasal congestion associated with sinusitis
- temporarily relieves sinus congestion and pressure
WARNINGS
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 contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- diabetes
- thyroid disease
- heart disease
- high blood pressure
- trouble urinating due to enlargement of the prostate gland
When using this product
- do not exceed recommended dose
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not improve within 7 days or occur with fever
If pregrant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
- take every 4 to 6 hours
- do not exceed 4 doses in 24 hours
| adults and children 12 years & over | 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | ask a doctor |
OTHER INFORMATION
- store at controlled room temperature 15˚-30˚C (59˚-86˚F)
- see end flap for expiration date and lot number
INACTIVE INGREDIENTS
cellulose, croscarmellose sodium, dicalcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin
PRINCIPAL DISPLAY PANEL
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| Labeler — Rebel Distributors Corp (118802834) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Rebel Distributors Corp | 118802834 | RELABEL, REPACK | |
Revised: 03/2012 Rebel Distributors Corp
