Nasal Decongestant PE description, usages, side effects, indications, overdosage, supplying and lots more!

Nasal Decongestant PE

The Kroger Co.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

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

Warnings

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.

Ask a doctor before use if you have

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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).

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

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.Principal Display Panel

Kroger Nasal Decongestant PE Tablets

Nasal Decongestant PE

Phenylephrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-670
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Product Characteristics

Color Size Imprint Code Shape
RED 7 mm T234 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18 in 1 BLISTER PACK
2 18 in 1 BLISTER PACK
3 18 in 1 BLISTER PACK
4 NDC:30142-670-72 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-02-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.