PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet, film coated
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.

----------

Leader 44-531 Delisted

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
- muscular aches
- toothache
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

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 (1-800-222-1222) 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 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours unless directed by a doctor
- 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrose monohydrate, FD&C red #40, FD&C yellow #6, maltodextrin, povidone, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, sucralose, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

NDC 37205-593-78

Compare to Extra Strength Tylenol® EZ Tabs
active ingredient*

LEADER®

EXTRA STRENGTH
Pain Reliever
Acetaminophen

Pain Reliever/Fever Reducer • Contains No Aspirin

Easy to Swallow
Sweet Coated

Easy Tabs

100 TABLETS - 500 mg EACH

Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® EZ Tabs.
50844 REV0913B53112

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4527750 www.myleader.com 1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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

Leader44-531A

PAIN RELIEVER EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-593
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (sweet coating)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-593-71	1 in 1 CARTON	12/11/2005	08/29/2020
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:37205-593-78	1 in 1 CARTON	12/11/2005	08/29/2020
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	12/11/2005	08/29/2020

Labeler - CARDINAL HEALTH (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(37205-593)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(37205-593)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(37205-593)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(37205-593)

Revised: 10/2017

Document Id: 88cd3bab-1ca6-4fb7-8afe-ca363cc7fc14

Set id: c2a2555e-a4c0-4a0e-9596-f72876035116

Version: 7

Effective Time: 20171006

CARDINAL HEALTH