UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER- acetaminophen and diphenhydramine hydrochloride tablet, film coated 
Chattem, Inc.

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Unisom PM Pain Nighttime Sleep-Aid and Pain Reliever

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

Warnings

Liver warning: 

This product contains acetaminophen. Severe liver damage may occur if you take

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.

Keep out of reach of children.

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
SLEEPCAPS
TM 
30 Caplets

Unisom®
PM PAIN
SLEEPCAPSTM 
30 Caplets

UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER 
acetaminophen and diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (White and blue) Score2 pieces
ShapeOVALSize17mm
FlavorImprint Code UNISOM;PM;PAIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0040-21 in 1 CARTON12/01/2009
115 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41167-0040-31 in 1 CARTON12/01/200904/10/2018
220 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41167-0040-41 in 1 CARTON12/01/2009
330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/01/2009
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: 4610e25d-f72a-40b8-a755-d7a6e1cb43b9
Set id: 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb
Version: 8
Effective Time: 20231009
 
Chattem, Inc.