Label: MEDIQUE APAP EXTRA STRENGTH- acetaminophen tablet, film coated
MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated
MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 47682-175-13, 47682-175-33, 47682-175-48, 47682-175-64, view more
    47682-175-99, 47682-804-13, 47682-804-33, 47682-804-48, 47682-804-50, 47682-804-99, 47682-904-33, 47682-904-48
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 29, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • backahe
    • the common cold
    • toothache
    • premenstrual and menstrual cramps

    temporarily reduces fever

  • WARNINGS

    Warnings

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

    • more than 4,000 mg 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

    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 allergic to acetaminophen or any of the inactive ingredients
  • ASK DOCTOR

    Ask a doctor before use if you have

    • liver disease
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin
  • STOP USE

    Stop use and ask a doctor if

    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

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

    Keep out of reach of children.

    Overdose 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 older)

    • take 2 tablets every 6 hours while symptoms last.
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    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
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized corn starch*, sodium starch glycolate, stearic acid, titanium dioxide*

    * m ay contain

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medi-First XS Non-Aspirin 500 mg Label

    50 Tablets

    (25 x 2)

    Medi-First®

    Extra Strength

    Non-Aspirin

    Compare active ingredient to:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer Products

    Pull to Open

    Pain Reliever/Fever Reducer

    Aches, Fever ● Acetaminophen 500mg

    This Package is For Households Without Young Children

    Tamper Evident Unit Dose Packets

    MF

  • Medi-First Plus XS Non-Aspirin Label

    100 Tablets

    (50 x 2's)

    Medi First® Plus

    Extra Strength

    Non-Aspirin

    Acetaminophen

    Pull To Open

    This Package is For Households Without Young Children

    Pain Reliever/Fever Reducer

    Compare Active ingredient to:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer

    Tamper Evident Unit Dose Packets

    MFP

  • Medique XS APAP 500 mg Label

    Medique®

    Extra Strength

    APAP

    Non-Aspirin Tablets

    Tabletas sin Aspirina

    This Package is For Households Without Young Children

    Este Paquete Es Para Hogares Sin Ninos Pequenos.

    Pull to Open

    Pain Reliever/Fever Reducer ● Acetaminophen 500mg

    Alivia el Dolor/Reduce la Fiebre ● Acetaminofeno 500 mg

    Tire Para Abrir

    250 Tablets

    (125 x 2)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

    Medique

  • INGREDIENTS AND APPEARANCE
    MEDIQUE APAP EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-175-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    2NDC:47682-175-13250 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-175-3350 in 1 BOX12/30/2008
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-175-48125 in 1 BOX12/30/2008
    42 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:47682-175-6412 in 1 BOX12/30/2008
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-804
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-804-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-804-48125 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-804-13250 in 1 BOX12/30/2008
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-804-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    5NDC:47682-804-5025 in 1 BOX12/30/2008
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-904-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-904-48125 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 not finalpart34312/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-175, 47682-804, 47682-904) , repack(47682-175, 47682-804, 47682-904)