Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Sinus Congestion Tablet, Film Coated
FDA Label NDC 30142-853
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Sinus Congestion (NDC 30142-853). 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 sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
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.
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
Questions Or Comments?
1-800-632-6900
Principal Display Panel
Kroger®
COMPARE TO the active ingredient of SUDAFED PE® CONGESTION *See bottom panel
NDC 30142-853-07
Maximum Strength
Sinus Congestion
Phenylephrine HCl 10 mg
Nasal Decongestant
NON-DROWSY
RELIEVES:
• Sinus Pressure
• Nasal & Sinus Congestion
actual size
36 TABLETS
Our Pharmacists Recommended
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
QUALITY GUARANTEE
800 632-6900 | www.kroger.com
*Sudafed PE® Congestion is a registered trademark of Johnson & Johnson Corporation, New Brunswick, NJ 08933. Johnson & Johnson Corporation is not affiliated with the Kroger Co. or this product.
50844 ORG082045307
Kroger 44-453 (Kroger 44 453 Sinus Congestion 1)
* Please review the disclaimer below.
