Sudogest
FDA Label NDC 21695-806

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Sudogest (NDC 21695-806). 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 drug facts, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

 

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

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 contains an MAOI, ask a doctor or pharmacist before taking this product.

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

    •  

When Using This Product

  • do not exceed recommended dose

    •  

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • 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 The Reach Of Children.

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

Directions

  • take every 4 to 6 hours
  • do not exceed 4 doses in 24 hours

    • adults and children 12 years & over 2 tablets 
    children 6 to under 12 years 1 tablet 
    children under 6 years ask a doctor 

Other Information

  • store at controlled room temperature 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

* Please review the disclaimer below.