Unisom PM Pain Nighttime Sleep Aid and Pain Reliever description, usages, side effects, indications, overdosage, supplying and lots more!

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever

Chattem, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Unisom PM Pain Nighttime Sleep-Aid and Pain Reliever



FULL PRESCRIBING INFORMATION

Drug Facts

(in each caplet)

Acetaminophen 325 mg

Pain reliever

(in each caplet)

Diphenhydramine HCl 50 mg

Nighttime sleep-aid

  • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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
  • 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

you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers
  • drowsiness will occur
  • avoid alcoholic drinks 
  • do not drive a motor vehicle or operate machinery
  • 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.

ask a health professional before use.

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.

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

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)

Unisom ®
PM PAIN
SLEEPCAPS TM  
30 Caplets

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever

Acetaminophen and Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41167-0040
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
hydroxypropyl cellulose
hypromellose
magnesium silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
STARCH, PREGELATINIZED CORN
STEARIC ACID
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White and blue) 20 mm UNISOM;PM;PAIN OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 20 in 1 BOTTLE
3 30 in 1 BOTTLE
4 NDC:41167-0040-4 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2009-12-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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