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Pain Reliever PM (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

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

Pain Reliever PM tablet, 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 products 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
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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 a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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 (1-800-222-1222) right away. 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

Other Information

  • store between 20-25°C (68-77°F)
  • avoid high humidity and excessive heat

Inactive Ingredients


croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone K30, pregelatanized starch, purified water, silicon dioxide, sodium starch glycolate,  talc, titanium dioxide



Questions Or Comments?


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Principal Display Panel


†Compare to the active ingredients in Extra strength Tylenol® PM

Extra Strength

Pain Reliever PM 

Acetaminophen 500 mg Pain reliever

Diphenhydramine HCL 25 mg Nighttime Sleep Aid

Non-Habit Forming

For ages 123 years and over

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: Wal-Mart Inc.,

Bentonville, AR 72716



Package Label

EQUATE Pain Reliever 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."

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"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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