Label: MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 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
    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 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 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 (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, pregelatinized corn starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*

    *may contain

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    SERIALIZED LABEL

  • INGREDIENTS AND APPEARANCE
    MEDIQUE APAP EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED 
    medique apap extra strength acetaminophen tablet, film coated tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51662-1274(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
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51662-1274-22 in 1 PACKET; Type 0: Not a Combination Product01/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/02/2024
    Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Establishment
    NameAddressID/FEIBusiness Operations
    HF Acquisition Co LLC, DBA HealthFirst045657305relabel(51662-1274)