LEADER PAIN RELIEVER EXTRA STRENGTH- 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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Cardinal Health Pain Reliever Caplets Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

•
more than 8 caplets 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

•
pain gets worse or lasts for more than 10 days
•
fever gets worse or lasts for 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning)

adults and children 12 years and over

•
take 2 caplets every 6 hours as needed
•
swallow whole – do not crush, chew or dissolve
•
do not take more than 8 caplets in 24 hours

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

flavors, hypromellose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, titanium dioxide *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Extra Strength Tylenol® Cool Caplets active ingredient

See New Warnings Information

Extra Strength

Pain Reliever

Acetaminophen

Contains No Aspirin

Pain Reliever/Fever Reducer

Easy to Swallow

Instant Cooling Sensation

Cool Ice® Caplets

500 mg Each

Actual Size

Pain Reliever Carton

Pain Reliever Carton

Pain Reliever Carton

LEADER PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-488
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (tablet) Size17mm
FlavorVANILLA (Menthol) Imprint Code L010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-488-781 in 1 CARTON06/01/200505/11/2013
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/200505/11/2013
Labeler - Cardinal Health (097537435)

Revised: 11/2017
Document Id: f48e9f39-102e-4e40-8b79-7976a1b5ef50
Set id: 5530eeaf-dae5-4a05-9a8b-e14b08bad035
Version: 3
Effective Time: 20171113
 
Cardinal Health