PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet, film coated

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/11/2005	08/29/2020

Labeler - CARDINAL HEALTH (097537435)

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

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

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

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