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Medi First Sinus Pain and Pressure

Medically reviewed on May 21, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-819

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.

819R Sinus Pain and Pressure UniFirst MF/MFP OC

Drug Facts

Active ingredients (in each tablet)

Acetaminophen     500mg

Phenylephrine HCl     5mg

Purposes

Pain reliever

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to

■ common cold

■ hay fever or other respiratory allergies

Temporarily

■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

■ reduces fever

Temporarily relieves minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ common cold

■ toothache

■ menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 8 tablets in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

■ 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

■ liver disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ heart disease

■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ symptoms do not improve within 7 days or are accompanied by a fever

■ pain or fever persists or gets worse

■ redness or swelling is present

■ any new symptoms appear

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ tamper evident sealed packets

■ do not use any opened or torn packets

■ avoid excessive heat and humidity

Inactive ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.

*may contain

Questions or comments? 1-800-634-7680

819R OC Mygrex Label

Otis Clapp

Quality and Integrity Since 1840

MYGREX ™

Pain Reliever-Decongestant

New Formula

Advanced Relief

For Sinus/Headaches

See Warnings and Directions on Side Panel

Acetaminophen 500 mg,

Phenylephrine HCl 5 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)

819R MF Sinus Pain and Pressure Label

500 Tablets

(250 x 2)

Medi-First ®
Sinus Pain and Pressure

Aches & Feveer • Acetaminophen 500 mg
Doleres, Fibre • Acetaminofeno 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg
Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg

Alivio al dolor y presiòn en los

senos nasales

Pull to Open
Tire Para Abrir
Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

819R MFP Sinus Pain and Pressure Label

100 Tablets

(50 x 2's)

Medi First ® Plus

Sinus Pain and Pressure

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Pull to Open

Sinus Pain Relief

Tamper Evident Unit Dose Packets

MEDI FIRST SINUS PAIN AND PRESSURE 
acetaminophen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-819
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
POVIDONE 
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint CodeAZ;261
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-819-3350 PACKET in 1 BOX, UNIT-DOSE
12 TABLET in 1 PACKET
2NDC:47682-819-48125 PACKET in 1 BOX, UNIT-DOSE
22 TABLET in 1 PACKET
3NDC:47682-819-13250 PACKET in 1 BOX, UNIT-DOSE
3NDC:47682-819-992 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2008
MEDI FIRST PLUS SINUS PAIN AND PRESSURE 
acetaminophen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-919
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
POVIDONE 
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint CodeAZ;261
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-919-3350 PACKET in 1 BOX, UNIT-DOSE
12 TABLET in 1 PACKET
2NDC:47682-919-48125 PACKET in 1 BOX, UNIT-DOSE
22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2008
OTIS CLAPP MYGREX 
acetaminophen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-509
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
POVIDONE 
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint CodeAZ;261
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-509-03150 PACKET in 1 BOX, UNIT-DOSE
1NDC:47682-509-992 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2008
Labeler - Unifirst First Aid Corporation (832947092)

 
Unifirst First Aid Corporation

← See all Medi First Sinus Pain and Pressure brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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