Active Ingredients (In Each Tablet)
Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg
Sinus And Allergy Relief Pe Tablet
FDA Label NDC 36800-642
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Sinus And Allergy Relief Pe (NDC 36800-642). 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
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution 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
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, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments?
1-888-423-0139
Principal Display Panel
+TopCare®
health
NDC 36800-642-08
MAXIMUM STRENGTH
Sinus & Allergy Relief PE
CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE
PHENYLEPHRINE HCl 10 mg - NASAL DECONGESTANT
RELIEVES:
• Sneezing • Sinus Congestion & Pressure
• Runny Nose • Itching of the Nose or Throat
• Nasal Congestion • Itchy, Watery Eyes
24 TABLETS
actual size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0621
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com
50844 ORG031946208
QUALITY GUARANTEED
This TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed.
Topcare 44-462 (Topcare 44 462 1)
* Please review the disclaimer below.
