Drug Facts
Active ingredient (in each tablet)
Phenylephrine HCL 10 mg
Physicianscare Sinus Tablet, Film Coated
FDA Label NDC 0924-0133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Physicianscare Sinus (NDC 0924-0133). 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 drug facts, purpose, indications & usage, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy 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
Indications & Usage
Uses
Temporarily relieves
■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ sinus congestion and pressure
Promotes nasal and/or sinus drainage.
Warnings
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
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
When Using This Product
■ do not exceed recommended dosage
Stop Use And Ask A Doctor If
■ you get nervous, dizzy or sleepless
■ symptoms do not improve within 7 days or are accompanied by fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ do not use more than directed
Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.
Children under 12 years: Do not give to children under 12 years of age
Other Information
■ read all product information before using
■ store at room temperature 59°-86° F (15°-30° C)
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredients
carnauba wax*, croscarmellose sodium, dicalcium phosphate*, FD&C red #40, FD&C yellow # 6, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol*, silicon dioxide*, stearic acid*, titanium dioxide
*may contain
Questions Or Comments?
1-800-835-2263
Physicianscare Sinus Label
Physicians Care®
Non-Drowsy Sinus
Decongestant Clears Sinus Pressure & Congestion
Pull To Open
Coated Tablets
Tamper-Evident Packets of 1 Tablet
50 Packets (1 Tablet 10 Mg Each)
* Please review the disclaimer below.
