DailyMed - TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (2024)

  • Label RSS
  • NDC Code(s): 36800-437-71, 36800-437-78
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 17, 2024

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  • Official Label (Printer Friendly)

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • Purpose

    Pain reliever

    Nighttime sleep-aid

  • Uses
  • 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

    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    with any other product containing diphenhydramine, even one used on skin
    in children under 12 years of age
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    liver disease
    glaucoma
    trouble urinating due to an enlarged prostate gland
    a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers
    taking the blood thinning drug warfarin

    When using this product

    drowsiness will occur
    avoid alcoholic drinks
    do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    pain gets worse or lasts more than 10 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur

    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.

  • Directions
    do not take more than directed (see overdose warning)

    adults and children

    12 years and over

    take 2 caplets at bedtime
    do not take more than 2 caplets of this product in 24 hours

    children under

    12 years

    do not use

  • Inactive ingredients

    carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health

    COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS

    EXTRA STRENGTH

    NIGHTTIME

    Pain Relief PM

    ACETAMINOPHEN 500 mg, DIPHENHYDRAMINE HCl 25 mg

    PAIN RELIEVER • NIGHTTIME SLEEP-AID

    Non-Habit Forming

    50 CAPLETS

    For Adults

    actual size

    PM

    DailyMed - TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (2)

  • INGREDIENTS AND APPEARANCE
    TOPCARE PAIN RELIEF PMEXTRA STRENGTH NON HABIT FORMING
    acetaminophen, diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-437
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorBLUE (Light blue) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L437;PM
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-437-711 in 1 CARTON07/21/1992
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:36800-437-781 in 1 CARTON07/21/199208/08/2015
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/21/1992

    Labeler -Topco Associates LLC(006935977)

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More Info on this Drug

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TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated

Number of versions: 9

Published Date (What is this?) Version Files
Jul 22, 2024 9 (current) download
May 23, 2023 8 download
Nov 16, 2021 7 download
Dec 3, 2019 6 download
Jun 21, 2018 5 download
Dec 19, 2017 4 download
Dec 9, 2015 3 download
Aug 28, 2012 2 download
Oct 9, 2010 1 download

RxNorm

TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated

RxCUI RxNorm NAME RxTTY
1 1092189 acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet PSN
2 1092189 acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet SCD
3 1092189 APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet SY

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TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated

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NDC Codes

TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated

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

NDC
1 36800-437-71
2 36800-437-78
DailyMed - TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (2024)
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