FDA.reportPublic FDA data

5427-Cardinal

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-24 05:10:14

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

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

Dosage and administration

● do not take more than directed (see overdose warning) adults 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily reduces fever and relieves minor aches and pains due to:

● headache

● muscular aches

● the common cold

● toothache

● backache

● minor pain of arthritis

● premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

● do not take more than directed (see overdose warning)

adults 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

Other information

OTHER SAFETY INFORMATION

Store in a dry place at 15° – 30°C (59° – 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, povidone, sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Extra Strength.

©2026 Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

CIN 5457262 REV. 06/26

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

100% Money Back Guarantee

Return to place of purchase.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0410-2

Extra Strength Acetaminophen

Tablets, 500 mg

Pain Reliever/ Fever Reducer

FOR ADULTS

Compare to Tylenol ® Extra Strength active ingredient*

100 Tablets

100% Money Back Guarantee

Leader labelLeader label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader labelLeader label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader LabelLeader Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0410-1EA - Each70000-0410b378b90c-e815-4422-a695-d839397a17e812019-08-06
70000-0410-2EA - Each70000-0410c93aa3f3-999c-4358-a756-ec1735f4d1ca12019-08-06
70000-0036-1EA - Each70000-0036e0209278-8ec0-470b-9987-4eeaf17a564e12020-02-13

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
70000-070970000-0709-1
70000-041070000-0410-2, 70000-0410-1
70000-003670000-0036-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-01-09full-release2026-06-01 00:53:19

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
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Inc.7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d2026-07-16WarningsExact identifier
ndc (package): 70000-0410-1
ndc (package): 70000-0036-1
ndc (package): 70000-0410-2
ndc (package): 70000-0709-1
ndc (product): 70000-0036
ndc (product): 70000-0709
ndc (product): 70000-0410
ndc11 (package): 70000070901
ndc11 (package): 70000003601
ndc11 (package): 70000041001
ndc11 (package): 70000041002
spl id: 56bd09ea-9506-021f-e063-6394a90a62f0
spl set id: 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d

Reported adverse events (FAERS/openFDA)#

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