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

  • NDC Code(s): 47682-272-13, 47682-272-33, 47682-272-48, 47682-272-64, view more
    47682-272-99, 47682-273-13, 47682-273-33, 47682-273-48, 47682-273-50, 47682-273-99, 47682-274-33, 47682-274-48
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 28, 2024

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

    ■ backache

    ■ minor pain of arthritis

    ■ 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 in this product

  • 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 using and ask a doctor if

    ■ pain gets worse or lasts more than for more than 10 days

    ■ fever gets worse or lasts more than 3 days

    ■ new symptoms occur

    ■ redness or swelling is present

    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    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 (see overdose warning)

    Adults and children 12 years and over
    ■ 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*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

    * May contain

  • PRINCIPAL DISPLAY PANEL

    Medique

    Extra Strength APAP

    Non-Aspirin Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    Pain Reliever / Fever Reducer • Acetaminophen 500 mg

    Compare active ingredient to Tylenol®

    Registered McNeil Products

    Tamper Evident Unit Dose Packets

    24 Tablets

    (12 x 2)

    175 APAPXS 17564 11-6-23 GR175R 90433 11-6-23 GR175R 80433 11-6-23 GR

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST PLUS EXTRA STRENGTH NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-274
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite ((White to Off-White)) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-274-3350 in 1 BOX03/28/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-274-48125 in 1 BOX03/28/2024
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/28/2024
    MEDI-FIRST EXTRA STRENGTH NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-273
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite ((White to Off-White)) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-273-13250 in 1 BOX03/28/2024
    1NDC:47682-273-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-273-3350 in 1 BOX03/28/2024
    2NDC:47682-273-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-273-48125 in 1 BOX03/28/2024
    3NDC:47682-273-992 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-273-5025 in 1 BOX03/28/2024
    4NDC:47682-273-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/28/2024
    MEDIQUE EXTRA STRENGTH APAP 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-272
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite ((White to Off-White)) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-272-13250 in 1 BOX03/28/2024
    1NDC:47682-272-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-272-3350 in 1 BOX03/28/2024
    2NDC:47682-272-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-272-48125 in 1 BOX03/28/2024
    3NDC:47682-272-992 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-272-6412 in 1 BOX03/28/2024
    4NDC:47682-272-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/28/2024
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(47682-272, 47682-273, 47682-274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(47682-272, 47682-273, 47682-274)