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SudoGest by Major Pharmaceuticals

Medically reviewed on July 27, 2017

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5351

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 44-111

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Pseudoephedrine HCl 60 mg

Purpose

Antihistamine
Nasal decongestant

Uses
  •  temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • diabetes
  • glaucoma
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

 taking sedatives or tranquilizers.

When using this product
  • do not exceed recommended dose
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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.

Directions
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years: do not use this product in children under 12 years of age

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • store in a dry place and protect from light
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-5351-96

SudoGest™
Sinus & Allergy
Maximum Strength

Chlorpheniramine maleate 4 mg
Pseudoephedrine hydrochloride 60 mg

ANTIHISTAMINE/NASAL DECONGESTANT

  • Nasal and Sinus Congestion
  • Sneezing
  • Runny Nose Due to Colds or Hay Fever
  • Itchy and Watery Eyes

48 TABLETS

50844     REV0712C11122

Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Rev. 02/16   Re-order No. 235632

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

SEALED IN BLISTER UNIT FOR YOUR PROTECTION

Major 44-111


SUDOGEST 
chlorpheniramine maleate, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code44;111
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5351-241 BLISTER PACK in 1 BOX
124 TABLET in 1 BLISTER PACK
2NDC:0904-5351-962 BLISTER PACK in 1 CARTON
224 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/16/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-5351)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-5351)

 
Major Pharmaceuticals

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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