sudogest

sudogest
SPL v1
SPL
SPL Set ID 656726ed-50cd-4f7e-8e51-e242afd1d9c9
Route
oral
Published
Effective Date 2009-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (30 mg)
Inactive Ingredients
croscarmellose sodium fd&c yellow no. 6 hypromelloses magnesium stearate polydextrose polyethylene glycols titanium dioxide triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44112 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph final active Since 1994-10-01

Purpose

Nasal decongestant

Description

 


Medication Information

Active Ingredient

Pseudoephedrine HCl 30 mg

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
Purpose

Nasal decongestant

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

Description

 

Principal Display Panel
Drug Facts

 

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.

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

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

Active Ingredient (Active Ingredient (in each tablet))

Pseudoephedrine HCl 30 mg

Uses (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
Purpose (PURPOSE)

Nasal decongestant

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Drug Facts (DRUG FACTS)

 

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

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)
  • you get nervous, dizzy or sleepless
  • 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 the Reach of Children. (Keep out of the 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
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the prostate gland

 


Advanced Ingredient Data


Raw Label Data

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