SUDO-TAB PE- phenylephrine hcl tablet 
HART Health

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.

----------

SUDO-TAB PE

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

Purpose:

Nasal Decongestant

Uses: Temporarily relieves nasal congestion and sinus pressure due to

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

Stop use and ask a doctor if

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:

Children under 12 years of age: ask a doctor

Other information

■ tablets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity

Inactive Ingredients: croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide. May contain propylene glycol.

SudoTabPE.jpg

SUDO-TAB PE 
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0126
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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-DOSE10/03/2005
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0126-7125 in 1 BOX, UNIT-DOSE10/03/2005
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0126-8250 in 1 BOX, UNIT-DOSE10/03/2005
32 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/03/2005
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: e0d2dc86-581f-4401-987b-cb8fbe7c6caf
Set id: 6f70ed59-a1f8-4daa-8614-feaf2533687b
Version: 4
Effective Time: 20230815
 
HART Health