EXTRA STRENGTH PAIN RELIEF PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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CVS 44-235

Active ingredients (in each caplet)

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

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the ative ingredients in Extra Strength Tylenol® PM*

SEE NEW WARNINGS INFORMATION

Extra Strength

PAIN RELIEF PM

CAPLETS

ACETAMINOPHEN

DIPHENHYDRAMINE HCl

Pain reliever / Nighttime sleep aid

24 CAPLETS

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

50844 REV0210F23508

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com 1-800-shop-CVS

Product Label

EXTRA STRENGTH PAIN RELIEF PM
acetaminophen and diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	59779-235
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
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
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	59779-235-08	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		24 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (59779-235-08)
2	59779-235-12	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
2		100 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (59779-235-12)
3	59779-235-13	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
3		250 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (59779-235-13)
4	59779-235-15	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
4		50 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (59779-235-15)
5	59779-235-29	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
5		150 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (59779-235-29)
6	59779-235-14	500 TABLET In 1 BOTTLE, PLASTIC	None

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

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 05/2011WOONSOCKET PRESCRIPTION CENTER,INCORPORATED