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 caplet)

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. The maximum daily dose of this product is 6 caplets (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.

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 of 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 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid

*may contain this ingredient

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC: 37205-594-78

LEADER®

Compare to
Extra Strength
Tylenol®
active ingredient†

EXTRA STRENGTH
Pain Reliever
Acetaminophen Contains No Aspirin
Pain Reliever/Fever Reducer

SATISFACTION
GUARANTEED

100 CAPLETS - 500 mg EACH

Actual Size

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

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Extra Strength Tylenol®
Caplets.                                                 50844             REV0213A17512

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4527669          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.

Leader 44-175

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-594
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
CASTOR OIL (UNII: D5340Y2I9G)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-594-71	1 in 1 CARTON	04/02/1993
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 37205-594-78	1 in 1 CARTON	04/02/1993
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 37205-594-90	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/02/1993

Labeler - CARDINAL HEALTH (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(37205-594)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(37205-594) , PACK(37205-594)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(37205-594)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(37205-594)