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Generic: acetaminophen and diphenhydramine hydrochloride 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


IMPRINT: UNISOM PM PAIN     SHAPE: oval
    COLOR: white    SCORE: 2

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Drug Facts

Active Ingredients


(in each caplet)

Acetaminophen 325 mg

Purposes


Pain reliever

Active Ingredients


(in each caplet)

Diphenhydramine HCl 50 mg

Purposes


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

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.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use


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

  • 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 serious 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.


O


Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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 older: • take 1 caplet at bedtime

• do not take more than 1 caplet of this product in 24 hours

children under 12 years: do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive Ingredients


blue 1 lake, croscarmellose sodium, dicalcium phosphate, hydroxypropylcellulose, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, PVP, silica, sodium carboxymethyl starch, stearic acid (283-056)

Principal Display Panel


Unisom ® PM PAIN SLEEPCAPS TM   30 Caplets



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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