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EXTRA STRENGTH ACETAMINOPHEN PM - acetaminophen and diphenhydramine hydrochloride tablet, coated 
McKesson (Health Mart)

Extra Strength Acetaminophen PM

Active ingredients (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 accompanying sleeplessness.

Warnings

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

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • 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.
  • with other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • 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 problems 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 a serious underlying 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

If pregnant or breast-feeding,

ask a health care 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 (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 overdose 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 product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

  • store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat

Inactive ingredients

colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,
polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

Principal Display Panel

Compare to Tylenol® PM caplets active ingredients**

EXTRA STRENGTH

Acetaminophen PM

Acetaminophen 500 mg,

Diphenhydramine HCl 25 mg

Pain reliever /nighttime Sleep-Aid

50 CAPLETS

Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM.

Healthmart

extra strength acetaminophen PM caplets



EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hcl  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62011-0025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
POVIDONES  
WATER  
SODIUM METABISULFITE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 7mm
Flavor Imprint Code V15AV;S525;CPC752
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62011-0025-1 1 BOTTLE In 1 BOX contains a BOTTLE
1 50 TABLET In 1 BOTTLE This package is contained within the BOX (62011-0025-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 06/04/2023

Labeler - McKesson (Health Mart) (177667227)
Registrant - P and L Development of New York Corporation (800014821)
Revised: 12/2012McKesson (Health Mart)