SUDO-TAB PE- phenylephrine hydrochloride 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.

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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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0126
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg
Inactive Ingredients
Ingredient Name Strength
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
Color red Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 271
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0126-4 50 in 1 BOX, UNIT-DOSE
1 2 in 1 PACKET
2 NDC:50332-0126-7 125 in 1 BOX, UNIT-DOSE
2 2 in 1 PACKET
3 NDC:50332-0126-8 250 in 1 BOX, UNIT-DOSE
3 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/03/2005
Labeler - HART Health (069560969)

Revised: 11/2012
Document Id: aff1a2e6-dfd0-48b3-ad03-f557602c58fd
Set id: 6f70ed59-a1f8-4daa-8614-feaf2533687b
Version: 1
Effective Time: 20121112
 
HART Health