nasal decongestant pe

nasal decongestant pe
SPL v1
SPL
SPL Set ID 9d030767-dfd6-48b4-9b17-4e20c23915f3
Route
oral
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (10 mg)
Inactive Ingredients
croscarmellose sodium dextrose monohydrate calcium phosphate, dibasic, dihydrate curry red lecithin, soybean magnesium stearate maltodextrin cellulose, microcrystalline silica cellulose gum trisodium citrate dihydrate ci 77891

Identifiers & Packaging

Pill Appearance
Imprint: 44;453 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-04-05

Purpose

Nasal decongestant

How Supplied

Product: 50090-7449 NDC: 50090-7449-0 18 TABLET, FILM COATED in a BLISTER PACK / 2 in a CARTON

Description

Phenylephrine HCl 10 mg


Medication Information

Active Ingredient

Phenylephrine HCl 10 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 over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

How Supplied

Product: 50090-7449

NDC: 50090-7449-0 18 TABLET, FILM COATED in a BLISTER PACK / 2 in a CARTON

Description

Phenylephrine HCl 10 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.

Phenylephrine Hcl
Questions Or Comments?

Call 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

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 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
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Phenylephrine HCl 10 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 over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: ask a doctor
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

How Supplied (HOW SUPPLIED)

Product: 50090-7449

NDC: 50090-7449-0 18 TABLET, FILM COATED in a BLISTER PACK / 2 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.

Phenylephrine Hcl (PHENYLEPHRINE HCL)
Questions Or Comments? (Questions or comments?)

Call 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

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 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)
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data


Raw Label Data

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