Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8eec9d31-5f60-49bb-a427-e8163c9c8078
Route
ORAL
Published
Effective Date 2014-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Calcium Phosphate, Dibasic, Dihydrate Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T234 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-02

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
  • temporarily relieves sinus congestion and pressure
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: do not use this product for children under 12 years of age
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.

Other Information
  • store at 20º-25ºC (68º-77ºF)
Inactive Ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

Questions Or Comments?

1-800-632-6900

Principal Display Panel

Compare to the active ingredient of SUDAFED PE® NASAL DECONGESTANT *See bottom panel

NON- DROWSY

Nasal Decongestant PE

Phenylephrine HCl Tablets

Nasal Decongestant

Does Not Contain Pseudoephedrine

MAXIMUM STRENGTH

Relieves:

  • Nasal & Sinus Congestion
  • Sinus Pressure

1 pill/dose

TABLETS 10 mg EACH

GLUTEN FREE

*Sudafed PE® is a registered trademark of McNeil Consumer Healthcare, Fort Washington, PA 19034. McNeil Consumer Healthcare is not affiliated with The Kroger Co. or this product.

EACH DOSE INDIVIDUALLY SEALED IN A BLISTER PACK . DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Kroger Nasal Decongestant PE Tablets

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 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).

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • high blood pressure
  • heart disease
  • 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
  • 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: do not use this product for children under 12 years of age
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.

Other Information (Other information)
  • store at 20º-25ºC (68º-77ºF)
Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel

Compare to the active ingredient of SUDAFED PE® NASAL DECONGESTANT *See bottom panel

NON- DROWSY

Nasal Decongestant PE

Phenylephrine HCl Tablets

Nasal Decongestant

Does Not Contain Pseudoephedrine

MAXIMUM STRENGTH

Relieves:

  • Nasal & Sinus Congestion
  • Sinus Pressure

1 pill/dose

TABLETS 10 mg EACH

GLUTEN FREE

*Sudafed PE® is a registered trademark of McNeil Consumer Healthcare, Fort Washington, PA 19034. McNeil Consumer Healthcare is not affiliated with The Kroger Co. or this product.

EACH DOSE INDIVIDUALLY SEALED IN A BLISTER PACK . DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Kroger Nasal Decongestant PE Tablets

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 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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)