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Extra Strength Pain Relief PM by Discount Drug Mart

Medically reviewed on June 18, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Discount Drug Mart
NDC Code: 53943-024

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.

ACTIVE INGREDIENT(S)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

PURPOSE

Pain reliever

Nighttime sleep aid

USE(S)

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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

ASK A DOCTOR BEFORE USE IF

You have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

ASK A DOCTOR OR PHARMACIST BEFORE USE IF
  • 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 DOCTOR IF
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

PREGNANCY/BREASTFEEDING

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 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

STORAGE
  • store between 20-25°C (68-77°F)
  • do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
  • see end panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, FD&C blue #1, Hypromellose, Microcrsytalline cellulose, Polyethylene glycol, Stearic acid, Titanium Dioxide. 

PRINCIPAL DISPLAY PANEL

Carton Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS







Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS





CARTON LABEL PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS





Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS





Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

300 COATED CAPLETS










EXTRA STRENGTH PAIN RELIEF PM 
acetaminophen 500mg diphenhydramine hcl 25mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-024
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 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
HYPROMELLOSES 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeP24
Contains    
Packaging
#Item CodePackage Description
1NDC:53943-024-501 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:53943-024-011 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:53943-024-03300 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/20/2013
Labeler - Discount Drug Mart (047741335)
Registrant - Discount Drug Mart (047741335)

 
Discount Drug Mart

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Further information

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

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