Your browser does not support JavaScript! SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]
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SUDO-TAB PE (phenylephrine hcl) tablet
[HART Health]


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

Active Ingredient (in each tablet): Phenylephrine HCl 5mg

Purpose: Nasal Decongestant

Uses: Temporarily relieves nasal congestion and sinus pressure due to

  • the common cold
  • hay fever
  • upper respiratory allergies

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), for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains and MAOI.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days
  • symptoms are accompanied by a 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. 1-800-222-1222

Directions: do not take more than directed

Adults and children 12 years of age and over:

  • take 2 tablets every 4 hours while symptoms persist
  • do not take more than 12 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Inactive Ingredients: Croscarmellose Sodium, FD&C Red #40, FD&C Yellow #6, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silicon Dioxide, Titanium Dioxide

SudoTabPE.jpg

SUDO-TAB PE 
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0126
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 271
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0126-450 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0126-7125 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0126-8250 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/03/2005
Labeler - HART Health (069560969)

Revised: 11/2012
 
HART Health

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