Active Ingredient (In Each Tablet) (Sinus Day)
Phenylephrine HCl 10 mg
Sinus Pressure And Congestion Relief Kit
FDA Label NDC 11822-9485
Full FDA labeling including 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 (NDC 11822-9485). 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) (sinus day), purpose, active ingredients (in each tablet) (sinus night), uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Antihistamine
Nasal Decongestant
Active Ingredients (In Each Tablet) (Sinus Night)
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- sneezing (Nighttime only)
- runny nose (Nighttime only)
- itchy, watery eyes (Nighttime only)
- itching of the nose or throat (Nighttime only)
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- sneezing (Nighttime only)
- runny nose (Nighttime only)
- 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.
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
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
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers. (Nighttime only)
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days or occur with fever
- nervousness, dizziness, or sleeplessness occur
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 (1-800-222-1222) right away.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.
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
- each tablet contains: calcium 25 mg (Nighttime only)
- 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 (Daytime Only)
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
Inactive Ingredients (Nighttime Only)
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Compare to the active ingredients in Sudafed PE® Day + Night Sinus Congestion*
SINUS PRESSURE & CONGESTION RELIEF PE
DAYTIME
PHENYLEPHRINE HCl
NASAL DECONGESTANT
NON-DROWSY
Relieves nasal
congestion
ACTUAL SIZE
NIGHTTIME
DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl
ANTIHISTAMINE,
NASAL DECONGESTANT
Relieves nasal
congestion
runny nose
ACTUAL SIZE
12 DAYTIME
TABLETS
8 NIGHTTIME
TABLETS
RITE
AID®
PHARMACY
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION GUARANTEE
if you're not satisfied, we'll
happily refund your money
*The product is not manufactured or distributed by
Johnson & Johnson, owner of the registered trademark
Sudafed PE® Day + Night Sinus Congestion.
50844 ORG011845348509
Rite Aid 44-453485 (Rite Aid 44 453485 1)
* Please review the disclaimer below.
