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ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: WALMART STORES INC
NDC Code: 49035-026

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.

ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Diphenhydramine HCl 25mgNighttime Sleep aid

Uses

for the 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 with this product if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while you are using this product

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 any 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 have

  • liver cirrhosis
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • trouble in urinating due to an enlargement of the 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 drinks
  • 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 for more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • 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.

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 (1-800-222-1222). 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 recommended (see overdose warning)
adults and children 12 years of age and over:
  • take 2 caplets at bedtime or as directed by a doctor
  • do not take more than 2 caplets in a 24 hour period
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 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration
  • each tablet contains: magnesium 0.05 mg

Inactive ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

Questions or comments?

1-888-287-1915

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

NDC 49035-026-50

equate®

Compare to
Extra Strength
Tylenol® PM
Active
Ingredients*

Extra Strength

Acetaminophen PM
Acetaminophen 500 mg , Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep Aid

Aspirin Free
Non-Habit Forming

50
CAPLETS

Actual Size

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-026
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
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeS525
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-026-501 BOTTLE in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE
2NDC:49035-026-202 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/01/2014
Labeler - WALMART STORES INC (051957769)
Establishment
NameAddressID/FEIOperations
ELYSIUM PHARMACEUTICALS LTD858352983MANUFACTURE(49035-026)

 
WALMART STORES INC

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Medically reviewed on May 22, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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