Sudogest

Sudogest
SPL v2
SPL
SPL Set ID 7d26821c-a08a-40a8-9729-251f21d54702
Route
ORAL
Published
Effective Date 2013-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (60 mg)
Inactive Ingredients
Hypromelloses Lactose Magnesium Stearate Polyethylene Glycols Silicon Dioxide Stearic Acid Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: 44;113 Shape: round Color: white Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 1994-10-01
Description

Pseudoephedrine HCl 60 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 60 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
Directions
  • adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use

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.

Other Information
  • store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Questions Or Comments?

(800)-616-2471

Principal Display Panel

MAJOR®

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 0904-5125-59

SudoGest™

NASAL DECONGESTANT  60 mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

100 TABLETS

Distributed by MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA   Rev. 01/13    M-17

50844  REV0712N11312

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Major 44-113
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 Pregrant 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.

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl 60 mg

Ask A Doctor Before Use If You Have
  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the prostate gland

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
Purpose

Nasal decongestant

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

Do Not Use (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.

Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

(800)-616-2471

Principal Display Panel (Principal display panel)

MAJOR®

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 0904-5125-59

SudoGest™

NASAL DECONGESTANT  60 mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

100 TABLETS

Distributed by MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA   Rev. 01/13    M-17

50844  REV0712N11312

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Major 44-113
When Using This Product (When using this product)

do not exceed recommended dose.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever
If Pregrant Or Breast Feeding, (If pregrant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Pseudoephedrine HCl 60 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:54.204870 · Updated: 2026-03-14T22:53:56.080797