Sudogest

Sudogest
SPL v17
SPL
SPL Set ID 065ad37b-5200-4b45-a626-4b29452b4ec7
Route
ORAL
Published
Effective Date 2021-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (60 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Stearic Acid Microcrystalline Cellulose Starch, Corn Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: 44;113 Shape: round Color: white Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 1984-12-07 Until 2018-10-31
Description

Pseudoephedrine HCl 60 mg

Purpose

Nasal decongestant

How Supplied

Product: 50090-0155 NDC: 50090-0155-1 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-0155-3 12 TABLET, FILM COATED in a BOTTLE NDC: 50090-0155-4 20 TABLET, FILM COATED in a BOTTLE NDC: 50090-0155-5 15 TABLET, FILM COATED in a BOTTLE

Medication Information

Purpose

Nasal decongestant

How Supplied

Product: 50090-0155

NDC: 50090-0155-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-3 12 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-4 20 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-5 15 TABLET, FILM COATED in a BOTTLE

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)
  • use by expiration date on package
Inactive Ingredients

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

Questions Or Comments?

(800) 616-2471

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
Pseudoephedrine Hydrochloride
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
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged 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.

How Supplied (HOW SUPPLIED)

Product: 50090-0155

NDC: 50090-0155-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-3 12 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-4 20 TABLET, FILM COATED in a BOTTLE

NDC: 50090-0155-5 15 TABLET, FILM COATED in a BOTTLE

Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • use by expiration date on package
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

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
Pseudoephedrine Hydrochloride
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
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:30.671245 · Updated: 2026-03-14T22:59:31.191887