Label: MEDI FIRST SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
MEDI FIRST PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
OTIS CLAPP MYGREX- acetaminophen, phenylephrine hydrochloride tablet

  • NDC Code(s): 47682-509-03, 47682-509-99, 47682-819-13, 47682-819-33, view more
    47682-819-48, 47682-819-50, 47682-819-99, 47682-919-33, 47682-919-48
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 2, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 500mg

    Phenylephrine HCl 5mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold/flu symptoms:

    ■ nasal congestion

    ■ headache

    ■ minor aches and pains

    ■ stuffy nose

    ■ sinus congestion and pressure

    temporarily reduces fever

  • WARNINGS

    Warnings

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

    ■ more than 4,000 mg of acetaminophen in 24 hours

    ■ with other drugs containing acetaminophen

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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening

    ■ blisters

    ■ rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    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.

    ■ 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.

    ■ for more than 10 days unless directed by a doctor

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ liver disease

    ■ thyroid disease

    ■ diabetes

    ■ high blood pressure

    ■ heart disease

    ■ trouble urinating due to an enlarged prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ■ taking the blood thinning drug warfarin

  • WHEN USING

    When using this product do not exceed recommended dosage.

  • STOP USE

    Stop use and ask a doctor if

    ■ you get nervous, dizzy, or sleepless

    ■ pain or nasal congestion gets worse or lasts more than 7 days

    ■ fever gets worse or lasts more than 3 days

    ■ redness or swelling is present

    ■ new symptoms appear

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Over dose warning:

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not use more than directed

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

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    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 INGREDIENT

    Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medi-First Plus Sinus Pain and Pressure Label

    100 Tablets
    (505 x 2's)
    Medi First ® Plus
    Sinus Pain and Pressure
    Aches & Fever • Acetaminophen 500mg

    Nasal Decongestant • Phenylephrine HCl 5 mg

    Pull to Open

    This Package is For Households Without Young Children.

    Sinus Pain Relief

    Tamper Evident

    Unit Dose Packet

    819R 91933 2-14-23

  • Otis Clapp Mygrex Label

    Otis Clapp
    Quality and Integrity Since 1840
    MYGREX ™
    Pain Reliever-Decongestant
    Advanced Relief
    For Sinus/Headaches
    See Warnings and Directions on Side Panel

    This package is for Households without Young Children.
    Acetaminophen 500 mg • Aches & Fever
    Phenylephrine HCl 5 mg • Nasal Decongestant
    Tear Out Along Perforation To Dispense
    PROFESSIONAL HEALTHCARE
    300 Tablets (150 PACKETS OF 2)

    819R Mygrex 12-28-20 my edit

  • Medi-First Sinus Pain and Pressure Label

    Medi-First ®
    Sinus Pain and Pressure

    Aches & Fever • Acetaminophen 500 mg

    Nasal Decongestant • Phenylephrine HCl 5 mg

    Pull to Open

    This Package is For Households Without Young Children.

    Tamper Evident Unit Dose Packets

    100 Tablets

    (50 x 2)

    819R 81933 2-14-23

  • INGREDIENTS AND APPEARANCE
    MEDI FIRST SINUS PAIN AND PRESSURE 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-819
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;261
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-819-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-819-48125 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-819-13250 in 1 BOX12/30/2008
    3NDC:47682-819-992 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-819-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    5NDC:47682-819-5025 in 1 BOX04/16/2019
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/30/2008
    MEDI FIRST PLUS SINUS PAIN AND PRESSURE 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-919
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;261
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-919-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-919-48125 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/30/2008
    OTIS CLAPP MYGREX 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;261
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-509-03150 in 1 BOX12/30/2008
    1NDC:47682-509-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-509-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)