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

Extra Strength Pain Relief PM by

Drug Labeling and Warnings

Extra Strength Pain Relief PM by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF PM 
acetaminophen 500mg diphenhydramine hcl 25mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-024
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-024-50	1 in 1 CARTON
1		50 in 1 BOTTLE
2	NDC: 53943-024-01	1 in 1 CARTON
2		100 in 1 BOTTLE
3	NDC: 53943-024-03	300 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	06/20/2013

Labeler - Discount Drug Mart (047741335)

Registrant - Discount Drug Mart (047741335)