Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 7aef00df-816a-4ea2-a2ad-beed66dd2fe4
Route
ORAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Propylene Glycol Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: round Color: red Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Phenylephrine HCl 10 mg

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Phenylephrine HCl 10 mg

Uses

temporarily relieves:

  • nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • nasal congestion associated with sinusitis 
  • sinus congestion and pressure
Directions
  • Adults and children 12 years of age and older: 
  • 1 tablet every 4 to 6 hours. 
  • Do not take more than 6 tablets in 24 hours
  • Children under 12 years of age: ask a doctor
Do Not Use

Do not use if you are now taking a prescription mono-amine 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.

Active Ingredient

Phenylephrine HCl 10 mg

Inactive Ingredients

croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Principal Display Panel
Decongestant PE
When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever
Keep Out of Reach of Children

In case of accidentaloverdose, contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

If pregnant or breast-feeding, ask a health professionalbefore use.

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

Uses

temporarily relieves:

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

Nasal Decongestant

Directions
  • Adults and children 12 years of age and older: 
  • 1 tablet every 4 to 6 hours. 
  • Do not take more than 6 tablets in 24 hours
  • Children under 12 years of age: ask a doctor
Do Not Use (Do not use)

Do not use if you are now taking a prescription mono-amine 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.

Active Ingredient (Active ingredient)

Phenylephrine HCl 10 mg

Inactive Ingredients

croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Principal Display Panel
Decongestant PE
When Using This Product (When using this product)

do not use more than directed

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 are accompanied by fever
Keep Out of Reach of Children

In case of accidentaloverdose, contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

If pregnant or breast-feeding, ask a health professionalbefore use.

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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