LEADER EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule, liquid filled

Leader Extra Strength Acetaminophen by

Drug Labeling and Warnings

Leader Extra Strength Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

STOP USE

■ 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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

INGREDIENTS AND APPEARANCE

LEADER EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0509
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)
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
Color	red (transparent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	GRAPE	Imprint Code	710
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0509-1	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/10/2019

Labeler - Leader™ (097537435)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(70000-0509)