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Pseudoephedrine Hydrochloride

Dosage form: tablet, coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-035

Pseudoephedrine HCl Tablets

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 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
  • ask a doctor

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

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeA;035
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-035-021 BLISTER PACK in 1 CARTON
124 TABLET, COATED in 1 BLISTER PACK
2NDC:57344-035-032 BLISTER PACK in 1 CARTON
224 TABLET, COATED in 1 BLISTER PACK
3NDC:57344-035-044 BLISTER PACK in 1 CARTON
324 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 01/2013
 
AAA Pharmaceutical, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.