Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Nasal Decongestant Pe
FDA Label NDC 30142-670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Nasal Decongestant Pe (NDC 30142-670). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product,, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 20°-25°C (68°-77°F)
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. Phenylephrine HCl 10 mg (Nasal Decongestant Pe 1) 
* Please review the disclaimer below.
