Sudogest Nasal Decongestant Tablet, Film Coated
FDA Label NDC 0904-6337

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Sudogest Nasal Decongestant (NDC 0904-6337). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

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

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

When Using This Product

do not exceed recommended dosage

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 (1-800-222-1222).

Directions

adults and children 12 years and over

  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours

children ages 6 to 12 years

  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other Information

  • each tablet contains: calcium 20 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive Ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions Or Comments?

1-800-616-2471

Principal Display Panel

COMPARE TO the active ingredient of SUDAFED® CONGESTION

SudoGest

NASAL DECONGESTANT

Pseudoephedrine Hydrochloride

Nasal & Sinus Congestion

Sinus Pressure

Actual Size

MAXIMUM STRENGTH

NON-DROWSY

24 TABLETS 30 mg EACH

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