Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Sinus Pressure And Congestion Relief Pe Tablet, Film Coated
FDA Label NDC 11822-4530
14 label sections · Submitted to the FDA by Rite Aid Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Sinus Pressure And Congestion Relief Pe (NDC 11822-4530). 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?
1-800-426-9391
Principal Display Panel
NDC 11822-4530-7
Compare to the active ingredient in
Sudafed PE® Sinus Congestion*
MAXIMUM STRENGTH
SINUS PRESSURE &
CONGESTION
RELIEF PE
PHENYLEPHRINE HCl 10 mg
NASAL DECONGESTANT
Relieves sinus pressure, sinus and nasal congestion
Pseudoephedrine free
NON-DROWSY
ACTUAL SIZE
36
TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Sudafed PE® Sinus Congestion.
50844 REV0820G45307
DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.
Rite Aid 44-453 (Rite Aid 44 453 1)
* Please review the disclaimer below.
