sunmark 44-112

sunmark 44-112
SPL v3
SPL
SPL Set ID 50e2d7d1-fc0f-4d78-a6e9-574e2abdd76a
Route
oral
Published
Effective Date 2020-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (30 mg)
Inactive Ingredients
croscarmellose sodium fd&c red no. 40 fd&c yellow no. 6 hypromellose, unspecified magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified titanium dioxide triacetin silicon dioxide dibasic calcium phosphate dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: 44;112 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph final active Since 1981-08-25

Purpose

Nasal decongestant

How Supplied

Product: 50090-3585 NDC: 50090-3585-3 30 TABLET in a BOTTLE

Description

Pseudoephedrine HCl 30 mg


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
  • temporarily relieves sinus congestion and pressure
Purpose

Nasal decongestant

Directions
adults and children

12 years and older 
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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

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

How Supplied

Product: 50090-3585

NDC: 50090-3585-3 30 TABLET in a BOTTLE

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?
1-800-426-9391
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
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.

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 30 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 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 (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

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

How Supplied (HOW SUPPLIED)

Product: 50090-3585

NDC: 50090-3585-3 30 TABLET 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.   

Pseudoephedrine Hcl (Pseudoephedrine HCl)
Questions Or Comments? (Questions or comments?)
1-800-426-9391
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
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.

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

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