Active Ingredients (In Each Tablet)
Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg
Sinus And Allergy Relief Pe Tablet
FDA Label NDC 11822-0462
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 And Allergy Relief Pe (NDC 11822-0462). 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 ingredients (in each tablet), purpose, 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- sinus congestion and pressure
- nasal congestion
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
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 in children under 12 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, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
RITE
AID®
PHARMACY
*Compare to the active ingredients in Sudafed PE® Sinus + Allergy
MAXIMUM STRENGTH
sinus & allergy
relief PE
chlorpheniramine maleate 4 mg, phenylephrine HCl 10 mg
antihistamine & nasal decongestant
relieves:
sinus pressure and congestion
sneezing, itchy eyes and runny nose
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 PE® Sinus + Allergy.
50844 REV0612B46208
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
Rite Aid 44-462 (Rite Aid 44 462 1)
* Please review the disclaimer below.
