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Unishield Sinus Decongestant Tablet, Film Coated
FDA Label NDC 49314-2083
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Sinus Decongestant (NDC 49314-2083). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Phenylephrine HCl 10 mg
Otc - Purpose
Purpose
Nasal decongestant
Indications & Usage
Temporarily relieves
■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ sinus congestion and pressure
Warnings
Warnings
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product
■ do not exceed recommended dosage
Otc - Stop Use
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 reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 tablets in 24 hours.
Children under 12 years: Ask a doctor
Other Safety Information
Other information
■ store at room temperature 59°-86° F (15°-30° C)
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide
Otc - Questions
Questions or comments? 800-480-5855
Unishield Sinus Decongestant Label
Unishield
Sinus Decongestant
Phenylephrine HCl 10 mg
100 Tablets/ 1 Tablet Per Packet
Pseudoephedrine Free Sinus Relief
Pull To Open
• For sinus headache, pain, pressure, and congestion
Compare active ingredients to:
Sudafed PE®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.
