DrugCite

EXTRA STRENGTH ACETAMINOPHEN PM  - acetaminophen and diphenhydramine hydrochloride capsule, liquid filled 
McKesson

Extra Strength Acetaminophen PM

Active ingredients (in each geltab)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain Reliver

Nighttime sleep aid

Uses

for temporary relief of occasional headaches, minor aches and pains accompanying sleeplessness.

Warnings

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

  • more than 2 geltabs 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
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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Ask a doctor before use if you have


  • liver disease
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland

Do not use

  • with other products 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 other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor 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

  • new symptoms occur
  • 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
  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

  • do not exceed recommended dose
  • adults and children 12 years of age and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs in 24 hours
  • children under 12 years of age: 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.

Other Information

  • store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

corn starch, DandC Red #27 aluminum lake, edible black ink, FDandC Blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate, stearic acid and titanium dioxide.

Questions or comments?

call toll free: 1-877-753-3935


Compare to the active ingredients in Tylenol PM (R)


SEE NEW WARNING INFORMATION

Extra Strength Acetaminophen PM
Acetaminophen 500mg  -  Diphenhydramine, HCl 25mg
Pain Reliever/Nighttime Sleep Aid
 50geltabs

McKesson Another Quality Product Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Guarantee
www.healthmart.com/healthmartbrand

Product Package Label

Extra Strength Pain Relief PM

Product Carton Label

Extra Strength Pain Relief PM


EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hydrochloride  capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62011-0024
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
STARCH, CORN  
D&C RED NO. 27  
ALUMINUM OXIDE  
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
HYPROMELLOSES  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POVIDONE  
WATER  
SILICON DIOXIDE  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color blue (BLUE) , white (WHITE) Score no score
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code BP50
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62011-0024-1 1 BOTTLE In 1 BOX contains a BOTTLE
1 50 CAPSULE In 1 BOTTLE This package is contained within the BOX (62011-0024-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/09/2022

Labeler - McKesson (177667227)
Revised: 04/2012McKesson