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

PHENYLEPHRINE 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)

Phenylephrine HCl 10 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 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
  • children under 12 years of age: ask a doctor

Other information

  • 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, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

RESTORE u

NDC 57344-131-03

†COMPARE TO THE ACTIVE
INGREDIENT IN SUDAFED PE®
NASAL DECONGESTANT

MAXIMUM
STRENGTH

NON-DROWSY

Nasal Decongestant PE

Phenylephrine HCl

Relieves: • Nasal & Sinus Congestion • Sinus Pressure

36 TABLETS - 10 mg each

Principal Display Panel - 36 Tablet Blister Pack Carton
PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A;131
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-131-021 in 1 CARTON
118 in 1 BLISTER PACK
2NDC:57344-131-032 in 1 CARTON
218 in 1 BLISTER PACK
3NDC:57344-131-044 in 1 CARTON
318 in 1 BLISTER PACK
4NDC:57344-131-051 in 1 CARTON
4150 in 1 BOTTLE, PLASTIC
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: 6e19e526-1f1c-41ba-90ff-bbaff1e3ecf8
Set id: 3ced476d-81c4-42c1-af09-dfa771f94690
Version: 1
Effective Time: 20130104
 
AAA Pharmaceutical, Inc.

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