OTC Medication Information: SudoGest

SUDOGEST- chlorpheniramine maleate and pseudoephedrine hydrochloride tablet
Major Pharmaceuticals

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
  • 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

  • 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

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

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
(click image for full-size original)

Major 44-111

SUDOGEST
chlorpheniramine maleate, pseudoephedrine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5351
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 44;111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-5351-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-5351-24)
2 NDC:0904-5351-96 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-5351-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 12/16/1992
Labeler — Major Pharmaceuticals (191427277)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0904-5351), pack (0904-5351)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (0904-5351)

Revised: 02/2024 Major Pharmaceuticals

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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