Unisom Pm Pain Nighttime Sleep-aid And Pain Reliever

Unisom Pm Pain Nighttime Sleep-aid And Pain Reliever
SPL v9
SPL
SPL Set ID 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb
Route
ORAL
Published
Effective Date 2026-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hydroxypropyl Cellulose, Unspecified Hypromelloses Magnesium Silicate Magnesium Stearate Cellulose, Microcrystalline Light Mineral Oil Starch, Corn Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: UNISOM;PM;PAIN Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-12-01 Until 2018-04-10

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

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.

Uses
  • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5

Drug Facts

Purposes

Pain reliever

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
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

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
Active Ingredients

(in each caplet)

Acetaminophen 325 mg

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)

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
Principal Display Panel

Unisom ®

PM PAIN

SLEEPCAPS
TM  

30 Caplets

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.

Ask A Doctor Or Pharmacist Before Use
  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

Structured Label Content

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.

Uses
  • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5 (42229-5)

Drug Facts

Purposes

Pain reliever

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
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

Do Not Use (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
Active Ingredients (Active ingredients)

(in each caplet)

Acetaminophen 325 mg

Inactive Ingredients (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)

Ask A Doctor Before Use (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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Unisom ®

PM PAIN

SLEEPCAPS
TM  

30 Caplets

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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