LEADER PAIN RELIEVER- acetaminophen tablet, 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.

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Cardinal Health Extra Strength Pain Reliever Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: headache
•: muscular aches
•: backache
•: minor pain of arthritis
•: the common cold
•: toothache
•: 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 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

•: new symptoms occur
•: redness or swelling is present
•: pain gets worse or lasts for more than 10 days
•: fever gets worse or lasts for more than 3 days

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

•: do not take more than directed (see Liver warning)
•: swallow whole – do not crush, chew or dissolve

adults and children 12 years and over	• take 2 tablets every 6 hours while symptoms last • do not take more than 8 tablets in 24 hours • do not use 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) and may cause liver damage

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carrageenan, corn starch*, croscarmellose sodium*, FD&C red #40 lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *contains one or more of these ingredients

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® EZ Tabs active ingredient

See New Warnings Information

Extra Strength

Pain Reliever

Acetaminophen - Contains No Aspirin

Pain Reliever/Fever Reducer

Easy to Swallow

Sweet Coated

Easy Tabs

500 mg each

Actual Size

Extra Strength Pain Reliever Carton

LEADER PAIN RELIEVER
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-711
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
CARRAGEENAN (UNII: 5C69YCD2YJ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONES (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	10mm
Flavor		Imprint Code	L227
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-711-71	1 in 1 CARTON	05/16/2006	03/22/2013
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:37205-711-78	1 in 1 CARTON	05/16/2006	03/22/2013
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	05/16/2006	03/22/2013

Labeler - Cardinal Health (097537435)

Revised: 11/2017

Document Id: c560fff5-43f0-4ec2-8bff-136edb05109a

Set id: e0db8fda-b4d9-412c-842e-f2dd99fab6ad

Version: 2

Effective Time: 20171113

Cardinal Health