EXTRA STRENGTH PAIN RELIEVER - acetaminophen tablet
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relieves minor aches and pains due to:
headache
the common cold
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 8 tablets in 24 hours, which is the maximum daily amount
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.

Ask a doctor before use if you are

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts 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. 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 tablets every 4 to 6 hours while symptoms last
do not take more than 8 tablets in 24 hours
do not take for more than 10 days unless directed by a doctor
children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen 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

povidone, pregelatinized starch, stearic acid

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®

SEE NEW WARNINGS INFORMATION

Extra Strength

PAIN RELIEF

TABLETS

ACETAMINOPHEN

Pain reliever / Fever reducer

CONTAINS NO ASPIRIN

10 TABLETS

500 mg each

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

50844 REV0710B14803

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Product Packaging

EXTRA STRENGTH PAIN RELIEVER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-101
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;148
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59779-101-03	10 TABLET (10 TABLET) in 1 VIAL, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/21/1993

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 08/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED