EXTRA STRENGTH PAIN RELIEVER - acetaminophen tablet
CARDINAL HEALTH

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 (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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, sodium starch glycolate*,stearic acid

*may contain this ingredient

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 37205-659-78

LEADER®

Compare to Extra Strength Tylenol® active ingredient

EXTRA STRENGTH

Pain Reliever

Acetaminophen • Contains No Aspirin

Pain Reliever/Fever Reducer

100 TABLETS

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

50844 REV0112A14812

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4550067

Leader 44-148

EXTRA STRENGTH PAIN RELIEVER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-659
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
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	44;148
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-659-72	1 BOTTLE (1 BOTTLE) in 1 CARTON	contains a BOTTLE
1		60 TABLET (60 TABLET) in 1 BOTTLE	This package is contained within the CARTON (37205-659-72)
2	NDC:37205-659-78	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
2		100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (37205-659-78)

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

Labeler - CARDINAL HEALTH (097537435)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	PACK

Revised: 08/2012 CARDINAL HEALTH