sudogest nasal decongestant

sudogest nasal decongestant
SPL v10
SPL
SPL Set ID 09feb5f0-c22d-4a1b-97a0-d5767e5f7730
Route
oral
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (30 mg)
Inactive Ingredients
copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified peg-20 sorbitan oleate silica ci 77891 curry red

Identifiers & Packaging

Pill Appearance
Imprint: L432 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 1991-09-10 Until 2023-12-31

Purpose

Nasal decongestant

How Supplied

Product: 50090-4345 NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

Description

Pseudoephedrine HCl 30 mg


Medication Information

Active Ingredient

Pseudoephedrine HCl 30 mg

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

Nasal decongestant

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 11 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

How Supplied

Product: 50090-4345

NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

Description

Pseudoephedrine HCl 30 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.

Pseudoephedrine Hcl
Questions Or Comments?

1-800-616-2471

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).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Pseudoephedrine HCl 30 mg

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

Nasal decongestant

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 11 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 (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 (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

How Supplied (HOW SUPPLIED)

Product: 50090-4345

NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

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.

Pseudoephedrine Hcl (Pseudoephedrine HCl)
Questions Or Comments? (Questions or comments?)

1-800-616-2471

When Using This Product (When using this product)

do not exceed recommended dosage

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 a fever
If Pregnant Or Breast Feeding, (If pregnant 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 (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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