Medi-First Sinus Decongestant

Medi-First Sinus Decongestant by

Drug Labeling and Warnings

Medi-First Sinus Decongestant by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDI-FIRST PLUS SINUS DECONGESTANT- phenylephrine hydrochloride tablet, coated 
MEDI-FIRST SINUS DECONGESTANT- phenylephrine hydrochloride tablet, coated 
Unifirst First Aid Corporation

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.

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Medi-First Sinus Decongestant

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

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

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

  • 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 59º-86º F (15º-30º 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? 1-800-634-7680

Medi-first Sinus Decongestant Label

24 Tablets

(24 x 1)

Medi-First®

Sinus Decongestant

Compare active ingredients to:

Sudafed® PE

Registered Trademark of Pfizer Consumer

Nasal Decongestant ● Phenylephrine HCl 10mg

Tamper Evident Unit Dose Packets

Medi-First

Medi-First Plus Sinus Decongestant Label

100 Tablets

(100 x 1's)

Medi-First® Plus

Sinus Decongestant

Phenylephrine HCl 10mg

Pull To Open

Pseudoephedrine Free

Sinus Relief

Compare active ingredient to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

MFP Sinus

MEDI-FIRST PLUS SINUS DECONGESTANT 
phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-171
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (red) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code T;2;3;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-171-48250 in 1 BOX04/18/201909/01/2020
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 47682-171-33100 in 1 BOX04/18/201909/01/2020
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/18/201909/01/2020
MEDI-FIRST SINUS DECONGESTANT 
phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-170
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (red) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code T;2;3;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-170-6424 in 1 BOX12/02/2012
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 47682-170-33100 in 1 BOX12/02/2012
21 in 1 PACKET; Type 0: Not a Combination Product
3NDC: 47682-170-48250 in 1 BOX12/02/2012
31 in 1 PACKET; Type 0: Not a Combination Product
4NDC: 47682-170-13500 in 1 BOX12/02/2012
4NDC: 47682-170-461 in 1 PACKET; Type 0: Not a Combination Product
5NDC: 47682-170-461 in 1 PACKET; Type 0: Not a Combination Product01/02/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2012
Labeler - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Prestige Packaging170837962relabel(47682-170, 47682-171) , repack(47682-170, 47682-171)

Revised: 11/2019
 
Unifirst First Aid Corporation