FDA.reportPublic FDA data

Leader Extra Strength Acetaminophen Tablets, 500 mg

Manufacturer
Cardinal Health, Inc.
Effective date
2018-08-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:52:26

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure12 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed (see overdose warning)
  • ​a dults and children 12 years and over:
  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

OTC - QUESTIONS SECTION

Questions or Comments? call (800) 795-9775

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0150-3

Extra Strength

Acetaminophen

Tablets, 500 mg

Pain Reliever / Fever Reducer

FOR ADULTS

Aspirin Free

225 TABLETS

Leader APAP 500 mg Tabs 0150-3Leader APAP 500 mg Tabs 0150-3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0150-1EA - Each70000-0150ad23bdab-bc1f-4dd1-b8d8-80b7555273ad12017-12-14
70000-0150-2EA - Each70000-01500a6a6e6c-3974-44f6-9e2d-39344df1b44612017-12-14
70000-0150-3EA - Each70000-01505b3613ac-8f01-4d16-8f40-b92aad60f13212018-03-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-015070000-0150-3, 70000-0150-1, 70000-0150-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7483083a-45ee-c3db-e053-2991aa0ae440415e373b-476d-1399-e054-00144ff8d46c2018-08-28WarningsExact identifier
spl id: 7483083a-45ee-c3db-e053-2991aa0ae440
spl set id: 415e373b-476d-1399-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.