Label: TOPCARE HEADACHE PM FORMULA- acetaminophen, diphenhydramine hcl tablet, film coated

  • 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 December 3, 2019

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

  • Active ingredients (in each tablet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

    (equiv. to Diphenhydramine citrate 38 mg)

  • Purposes

    Pain reliever

    Nighttime sleep-aid

  • Uses

    for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
  • 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
    a breathing problem such as emphysema or chronic bronchitis
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin
    taking sedatives or tranquilizers

    When using this product

    avoid alcoholic drinks
    drowsiness may occur
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    pain gets worse or lasts for more than 10 days
    fever gets worse or lasts for 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 use more than directed (see overdose warning)
    adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
    do not take more than 2 tablets of this product in 24 hours
    children under 12 years of age: do not use
  • Other information

    store at 20-25°C (68-77°F)
  • 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 or comments?

    1-888-423-0139

  • Principal Display Panel

    NON-HABIT FORMING – ASPIRIN FREE

    Headache PM Formula

    ACETAMINOPHEN

    DIPHENHYDRAMINE HCl

    Pain Reliever / Nighttime Sleep-Aid

    For Adults

    SEE NEW WARNINGS

    COMPARE TO EXCEDRIN® PM active ingredients

    actual size

    50 TABLETS

    TopCare Headache PM Formula Image 1
    TopCare Headache PM Formula Image 2
  • INGREDIENTS AND APPEARANCE
    TOPCARE HEADACHE PM FORMULA 
    acetaminophen, diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUND (shallow convex) Size11mm
    FlavorImprint Code L355;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-355-711 in 1 CARTON08/25/1997
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/25/1997
    Labeler - Topco Associates LLC (006935977)