Active Ingredient (In Each Tablet)
Pseudoephedrine HCl 30 mg
Sinus Pressure And Congestion Relief Tablet, Film Coated
FDA Label NDC 11822-0112
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 11822-0112). 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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- 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 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 older | take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours |
| children ages 6 to 12 years | take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours |
| children under 6 years | do not use this product in children under 6 years of age |
Other Information
- 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, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
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RITE
AID®
PHARMACY
*Compare to the active ingredient in Sudafed® Congestion
MAXIMUM STRENGTH
sinus pressure &
congestion relief
pseudoephedrine HCl 30 mg
nasal decongestant
NON-DROWSY
relieves:
sinus pressure
nasal and sinus congestion
ACTUAL SIZE
24 TABLETS
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Sudafed®
Congestion. 50844 REV0712A11208
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
SATISFACTION
RITE AID®
GUARANTEE
IF YOU’RE NOT
SATISFIED, WE’LL
HAPPILY REFUND
YOUR MONEY.
Rite Aid 44-112 Rev0712a (Rite Aid 44 112 1)
* Please review the disclaimer below.
