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
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

Medication Information

Active Ingredient

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
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
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

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

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.

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.

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

Active Ingredient (Active ingredient (in each tablet))

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
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
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

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

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.

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.

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