EXTRA STRENGTH PAIN RELIEF PM - acetaminophen 500mg diphenhydramine hcl 25mg tablet, coated 
Discount Drug Mart

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.

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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

DO NOT USE

ASK A DOCTOR BEFORE USE IF

You have

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

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

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

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



50ct-DDM-AD-carton




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



50ct-DDM-AD-Bot


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



100-DDM-AD-carton


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



100-DDM-AD-bottle


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



300-DDM-AD-bottle







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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-024-501 in 1 CARTON
150 in 1 BOTTLE
2NDC:53943-024-011 in 1 CARTON
2100 in 1 BOTTLE
3NDC:53943-024-03300 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)

Revised: 6/2013
Document Id: e85c204f-2be9-4650-95d6-65ba5e89f915
Set id: e85c204f-2be9-4650-95d6-65ba5e89f915
Version: 1
Effective Time: 20130618
 
Discount Drug Mart