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acetaminophen pm extra strength

Medically reviewed on June 15, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Sam's West Inc
NDC Code: 68196-556

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.

Members Mark 44-556

Active ingredients
(in each gelcap)

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:

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product 

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland 

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 beverages
  • 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 more than 10 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 (1-800-222-1222) right away.

Directions
  • do not take more than directed
  • adults and children 12 years and over
  • take 2 gelcaps at bedtime
  • do not take more than 2 gelcaps of this product in 24 hours
  • children under 12 years: do not use

Other information
  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity

Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Principal Display Panel

Compare to Extra Strength Tylenol® PM active ingredients*

Member's Mark®
QUALITY GUARANTEED

NDC 68196-556-54

rapid release
extra strength

acetaminophen pm
acetaminophen 500 mg/
pain reliever
diphenhydramine HCl 25 mg/
nighttime sleep aid

• Relieves headache, minor aches
  & pains accompanied
  by sleeplessness

actual size

375
Rapid Release
Gelcaps

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

50844   ORG031555654

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR72716

100% MONEY BACK GUARANTEE
SUPERIOR QUALITY AND PERFORMANCE
we would like to hear from you with any comments or suggestions.
In the continental U.S. or Canada, you can call us at 1-800-426-9391
from 8:30 a.m. to 4:00 p.m. EST Monday-Friday.

Members Mark L-556-54

ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-556
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
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
GELATIN 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
AMMONIA 
SILICON DIOXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
STARCH, CORN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
Product Characteristics
ColorBLUE (light blue) , BLUE (dark blue) Scoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;6
Contains    
Packaging
#Item CodePackage Description
1NDC:68196-556-54375 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/17/2007
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68196-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(68196-556), PACK(68196-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(68196-556)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(68196-556)

 
Sam's West Inc

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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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