PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, coated
AAA Pharmaceutical, Inc.
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.
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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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product
-
do not use more than directed
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by 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 children 12 years of age and over |
- take 2 tablets every 4 to 6 hours
- do not take more than 8 tablets in 24 hours
|
| children 6 to under 12 years of age |
- take 1 tablet every 4 to 6 hours
- do not take more than 4 tablets in 24 hours
|
| children under 6 years of age |
|
Other information
- each tablet contains: calcium 25 mg
- store at 15°-25°C (59°-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton
RESTORE u
NDC 57344-035-02
†COMPARE TO THE ACTIVE
INGREDIENT IN SUDAFED®
NASAL DECONGESTANT
MAXIMUM
STRENGTH
NON- DROWSY
Nasal Decongestant
Pseudophedrine HCl
Relieves: • Nasal & Sinus Congestion • Sinus Pressure
24 TABLETS - 30 mg each
AAA Pharmaceutical, Inc.
