Your browser does not support JavaScript! PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.]
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RxNorm Names

PSEUDOEPHEDRINE HYDROCHLORIDE tablet, coated
[AAA Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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

Principal Display Panel - 24 Tablet Blister Pack Carton
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 Code A;035
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-035-021 in 1 CARTON
124 in 1 BLISTER PACK
2NDC:57344-035-032 in 1 CARTON
224 in 1 BLISTER PACK
3NDC:57344-035-044 in 1 CARTON
324 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
Document Id: 0f500946-18c8-4139-8f09-3bf58fd85c95
Set id: 5377d4dd-aad1-4820-bc05-e7dbb152c0f5
Version: 1
Effective Time: 20130104
 
AAA Pharmaceutical, Inc.

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