UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER- acetaminophen and diphenhydramine hydrochloride tablet

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever by

Drug Labeling and Warnings

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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
SLEEPCAPSTM 
30 Caplets

INGREDIENTS AND APPEARANCE

UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER 
acetaminophen and diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0040
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (White and blue)	Score	2 pieces
Shape	OVAL	Size	20mm
Flavor		Imprint Code	UNISOM;PM;PAIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0040-2	1 in 1 CARTON	12/01/2009
1		15 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41167-0040-3	1 in 1 CARTON	12/01/2009	04/10/2018
2		20 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41167-0040-4	1 in 1 CARTON	12/01/2009
3		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/01/2009

Labeler - Chattem, Inc. (003336013)