UNISHIELD SINUS DECONGESTANT- phenylephrine hcl tablet, film coated 
Unishield

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Unishield Sinus Decongestant

DRug Factr

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

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

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 (1-800-222-1222).

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 information

■ store at room temperature 59º-86º F (15º-30º C)

■ tamper evident sealed packets

■ do not use any opened or torn packets

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

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

208R

UNISHIELD SINUS DECONGESTANT 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-2083
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-2083-3100 in 1 BOX03/01/2021
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2021
Labeler - Unishield (790677053)
Registrant - Unifirst First Aid Corporation (832947092)

Revised: 3/2022
Document Id: da55994d-b70c-29c0-e053-2995a90a2e0e
Set id: b8f68d9d-2d38-414a-e053-2a95a90a15ec
Version: 3
Effective Time: 20220316
 
Unishield