Sudogest PE

Dosage form: tablet, film coated
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5733

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.

Major 44-453

Active ingredient(s)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Use(s)
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

  • 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
  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

When using this product
  • do not exceed recommended dose

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur

  • symptoms do not improve within 7 days or occur with 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
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

  • children under 12 years: do not use this product in children under 12 years of age

Other information
  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional pakaging may also be available.

Non-Drowsy

MAJOR®

SUDOGEST™ PE

NASAL DECONGESTANT

Phenylephrine HCl, 10 mg each

Does not contain Pseudoephedrine

  • Nasal & Sinus Congestion
  • Sinus Pressure

*Compare to the active

ingredient in Sudafed PE®

1 Pill Per Dose

36 TABLETS

10 mg each

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA                                 M-17

Rev. 10/10                  Re-order No. 100112

Product Packaging

SUDOGEST PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5733
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DEXTROSE MONOHYDRATE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5733-731 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
136 TABLET, FILM COATED (36 TABLET) in 1 BLISTER PACK
2NDC:0904-5733-491 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
218 TABLET, FILM COATED (18 TABLET) in 1 BLISTER PACK
3NDC:0904-5733-621 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
372 TABLET, FILM COATED (72 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/06/2004
Labeler - Major Pharmaceuticals (191427277)

Revised: 04/2011
 
Major Pharmaceuticals

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Advertisement
Close

Recommended

(web4)