DrugCite

EXTRA STRENGTH ACETAMINOPHEN PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated 
Wal-Mart Stores Inc

Equate 44-235

Active ingredients

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

  • 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

  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • 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 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.

  • 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 caplets at bedtime. Do not take more than 2 caplets 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 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

equate®

NDC 49035-235-15

Compare to Extra Strength Tylenol® PM Caplets Active Ingredients*

Extra Strength
Acetaminophen PM
Acetaminophen, Diphenhydramine HCl
Pain Reliever/Nighttime Sleep Aid

Aspirin Free
Non-Habit Forming

50 CAPLETS

Distributed by: Wal-Mart Stores, Inc.
Benttonville, AR 72716     © Wal-Mart Stores, Inc.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM Caplets.
50844   0410E23515

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

Equate 44-235

Equate 44-235


EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen and diphenhydramine hcl  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 49035-235
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  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
POVIDONES  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 44;235
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49035-235-15 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (49035-235-15)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/15/1994

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