Unisom Pm Pain Nighttime Sleep Aid And Pain Reliever Tablet, Film Coated
FDA Label NDC 41167-0040

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Unisom Pm Pain Nighttime Sleep Aid And Pain Reliever (NDC 41167-0040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each caplet)

Acetaminophen 325 mg

(in each caplet)

Diphenhydramine HCl 50 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

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 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 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.

Overdose Warning:

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
SLEEPCAPSTM 
30 Caplets

Unisom®pm Painsleepcapstm 30 Caplets (Unisom Pm Pain Nighttime Sleep Aid And Pain Reliev 01)

Unisom®pm Painsleepcapstm 30 Caplets (Unisom Pm Pain Nighttime Sleep Aid And Pain Reliev 01)

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