DailyMed - MEDIQUE AT HOME APAP EXTRA STRENGTH (2025)

  • Label RSS
  • NDC Code(s): 47682-433-33, 47682-433-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2025

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

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  • Official Label (Printer Friendly)

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Puropse

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:

    ■ the common cold

    ■ headache

    ■ backache

    ■ minor pain of arthritis

    ■ toothache

    ■ muscular aches

    ■ 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 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 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 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.

  • 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.

    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.

  • 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 child resistant packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

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

    * May contain

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique® @ Home

    APAP Extra Strength Tablets

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    Pull to Open

    Child-Resistant Packets

    *not the actual size

    50 Packets

    (2 Tablets Per Packet)

    Compare to the active ingredient in Extra Strength Tylenol® Tablets

    DailyMed - MEDIQUE AT HOME APAP EXTRA STRENGTH (2)

  • INGREDIENTS AND APPEARANCE
    MEDIQUE AT HOME APAP EXTRA STRENGTH
    acetaminophen 500 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-433
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    POVIDONE (UNII: FZ989GH94E)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    STARCH, CORN (UNII: O8232NY3SJ)
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-433-3350 in 1 BOX02/01/2021
    1NDC:47682-433-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-433-992 in 1 PACKET; Type 0: Not a Combination Product02/01/2021
    DailyMed - MEDIQUE AT HOME APAP EXTRA STRENGTH (3)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2021

    Labeler -Unifirst First Aid Corporation(832947092)

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More Info on this Drug

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MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated

Number of versions: 8

Published Date (What is this?) Version Files
Feb 10, 2025 8 (current) download
Jan 29, 2025 7 download
Nov 11, 2024 6 download
Jun 9, 2023 5 download
Feb 24, 2023 4 download
Mar 18, 2022 3 download
Jul 9, 2021 2 download
Feb 1, 2021 1 download

RxNorm

MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated

RxCUI RxNorm NAME RxTTY
1 198440 acetaminophen 500 MG Oral Tablet PSN
2 198440 acetaminophen 500 MG Oral Tablet SCD
3 198440 APAP 500 MG Oral Tablet SY

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NDC Codes

MEDIQUE AT HOME APAP EXTRA STRENGTH- acetaminophen 500 mg tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 47682-433-33
2 47682-433-99
DailyMed - MEDIQUE AT HOME APAP EXTRA STRENGTH (2025)
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