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Leader Pain Reliever PM

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 37205-060

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cardinal Health Pain Reliever PM Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses

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
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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 lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning).

Adults and children 12 years and over:

  • take 2 caplets at bedtime
  • do not take more than 2 caplets 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

carnauba wax, crospovidone, FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

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Compare to Tylenol® PM active ingredients

Extra Strength

Pain Reliever PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever/Nighttime Sleep Aid

Non-habit forming

Caplets

Pain Reliever PM Carton Image 1

Pain Reliever PM Carton Image 2

LEADER PAIN RELIEVER  PM
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-060
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
POVIDONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (Light blue) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeL437;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-060-711 BOTTLE (BOTTLE) in 1 CARTON
150 TABLET, FILM COATED (TABLET) in 1 BOTTLE
2NDC:37205-060-781 BOTTLE (BOTTLE) in 1 CARTON
2100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33807/07/1992
Labeler - Cardinal Health (097537435)

Revised: 05/2009
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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