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Topcare pain relief PM (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. Topco Associates LLC

Generic: acetaminophen, diphenhydramine hcl is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain

Topcare pain relief PM tablet, film coated - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose


Pain reliever

Nighttime sleep-aid

Uses


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

    adults and children

    12 years and over
    • •

    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

    DISCLAIMER:

    "This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

    "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

    "This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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