SUDOGEST- chlorpheniramine maleate, pseudoephedrine hcl tablet 
Major Pharmaceuticals

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Major 44-111

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Pseudoephedrine HCl 60 mg

Purpose

Antihistamine
Nasal decongestant

Uses

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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution 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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-5351-24

Maximum Strength
SudoGest 
Sinus & Allergy

Chlorpheniramine Maleate 4 mg
Pseudoephedrine HCl 60 mg

4 mg/60 mg

Antihistamine/Nasal Decongestant

Runny Nose & Sneezing,
Itchy, Watery Eyes,
Sinus Congestion & Pressure

24 Tablets

Actual Size

50844     REV0619L11108

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com

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

Major 44-111

Major 44-111


SUDOGEST 
chlorpheniramine maleate, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code 44;111
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5351-241 in 1 CARTON12/16/1992
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0904-5351-962 in 1 CARTON12/16/199201/31/2023
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/16/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0904-5351) , pack(0904-5351)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(0904-5351)

Revised: 2/2024
Document Id: 846a914d-612e-4b0a-87c6-0eeb614dc5c5
Set id: 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9
Version: 19
Effective Time: 20240219
 
Major Pharmaceuticals