LEADER EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule, liquid filled 
Cardinal Health

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Leader™ Extra Strength Acetaminophen

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

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.

■ 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

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 Overdose warning)

 Adults and children 12 years and over ■ take 2 softgels every 6 hours while
symptoms last
■ do not take more than 6 softgels in
24 hours unless directed by a doctor
■ do not use for more than 10 days
unless directed by a doctor
 children under
12 years
 ask a doctor

Other information

each softgel contains: sodium 7 mg
■ store between 15°-30°C (59°-86°F)

Inactive ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,
potassium hydroxide, povidone, propylene glycol, purified
water, sodium hydroxide, sorbitol, sorbitol sorbitan solution
titanium dioxide

Questions or Comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Leader™ Extra Strength Acetaminophen

Compare to the active ingredient
in Tylenol® Extra Strength*
Liquid-Filled Capsules**


EXTRA STRENGTH
Acetaminophen USP 500mg

Pain Reliever; Fever reducer
Aspirin free
40 SOFTGELS**
**Liquid filled capsules

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 Tylenol®
Extra Strength.

Distributed by: CARDINAL HEALTH
DUBLIN, OHIO 43017
Made in India
CIN 5546221

image description

LEADER EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0509
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (transparent) Scoreno score
ShapeOVALSize23mm
FlavorGRAPEImprint Code 710
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0509-140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/10/2019
Labeler - Cardinal Health (063997360)

Revised: 12/2023
Document Id: 0bb70789-af21-4ff0-e063-6394a90acdfc
Set id: 01f6428d-259c-4f02-8c69-6130b897373e
Version: 9
Effective Time: 20231204
 
Cardinal Health