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Acetaminophen PM Extra Strength

Medically reviewed on April 21, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: SUPERVALU INC.
NDC Code: 41163-956

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.

Equaline 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:

  • 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 

 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age 

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

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

When using this product
  • avoid alcoholic beverages
  • drowsiness will occur
  • 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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • 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 

Questions or comments?

1-877-932-7948 

Principal Display Panel

EQUALINE®

compare to
Extra Strength Tylenol® PM 

active ingredients*

NDC 41163-956-09

extra strength
acetaminophen PM gelcaps
acetaminophen 500mg
diphenhydramine HCl 25mg
pain reliever/nighttime sleep aid

• non-habit forming
• rapid release

20 gelcaps

actual size

DOES NOT CONTAIN GLUTEN

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

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com

50844     REV0615E55609

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

Equaline 44-556


ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-956
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
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SHELLAC 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (Light) , BLUE (Dark) Scoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;6
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-956-091 BOTTLE, PLASTIC in 1 CARTON
120 TABLET in 1 BOTTLE, PLASTIC
2NDC:41163-956-101 BOTTLE, PLASTIC in 1 CARTON
240 TABLET in 1 BOTTLE, PLASTIC
3NDC:41163-956-311 BOTTLE, PLASTIC in 1 CARTON
380 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/17/2007
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(41163-956)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(41163-956)

 
SUPERVALU INC.

← See all Acetaminophen PM Extra Strength brands

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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