DrugCite

EXTRA STRENGTH ACETAMINOPHEN PM - acetaminophen and diphenhydramine hydrochloride capsule 
Wal-Mart Stores Inc

Equate 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

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
  • trouble urinating due to an enlarged 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

  • drowsiness will occur
  • aboid alcoholic beverages
  • do not drive a motor vehicle or operate machiner 

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.

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. 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 gelcaps at bedtime. Do not take more than 2 gelcaps 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. 

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

 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, pregelatinied starch, propylene gllycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 49035-556-31

equate

Compare to The Active Ingredient of Extra Strength Tylenol® PM*

EXTRA STRENGTH
Acetaminophen PM
Acetaminophen
, Diphenhydramine HCl
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming

80 GELCAPS

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

50844        REV0712D55631

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

Equate 44-556

Equate 44-556


EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen and diphenhydramine hcl  capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 49035-556
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 RED NO. 3  
HYDROXYPROPYL CELLULOSE (TYPE H)  
HYPROMELLOSES  
POLYETHYLENE GLYCOLS  
PROPYLENE GLYCOL  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 44;556
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49035-556-31 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 80 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (49035-556-31)
2 49035-556-09 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
2 20 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (49035-556-09)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part341 12/17/2007

Labeler - Wal-Mart Stores Inc (051957769)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Revised: 10/2012Wal-Mart Stores Inc