Acetaminophen Tablet 500mg Mapap Tablets Extra Strength

Manufacturer: Cardinal Health
Effective date: 2018-06-20
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: legacy-cache
Hydrated at: 2026-08-02 00:54:11

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure9 sections

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: Do not use adult Extra Strength product in children under 12 years of age: this will provide more than the reco...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Acetaminophen 500mg (in each tablet)

ASPIRIN FREE EXTRA STRENGTH PAIN RELIEVER

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Use(s)

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains due to: headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, premenstrual and menstrual cramps.

temporarily reduces fever.

Warnings

WARNINGS SECTION

See New Warnings Information and Directions

This unit dose package is not child resistant and is intended for institutional use only. Keep out of reach of children.

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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.

Symptoms may include: - skin reddening – blisters – rash

If skin reactions occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

you have liver disease.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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.

Pregnancy/Breastfeeding

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.

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:

Do not use adult Extra Strength product in children under 12 years of age: this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions

OTC - QUESTIONS SECTION

Questions or comments? To Report Adverse Drug Event call (800) 616-2471.

Distributed by:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Distributed by Cardinal Health

Dublin, OH 43017

L4387353-10518

L4387353-20518

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mapap Tablets

Extra Strength Acetaminophen

500 mg

10 Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-1988-59	EA - Each	0904-1988	59e9faee-e3d5-4ff9-84b0-c685998bf694	1	2013-02-11
0904-1988-60	EA - Each	0904-1988	82c955b4-0ef5-44b8-89c9-fec81f411a3f	1	2013-02-11
0904-1988-61	EA - Each	0904-1988	f8dac616-228c-4c6d-a729-89cc45c9a11d	1	2013-02-13
0904-1988-80	EA - Each	0904-1988	e2e14895-8674-4abc-b0dc-0a23d8e44d32	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	11
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	11
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	11

Products#

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

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

Acetaminophen
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55154-0746	55154-0746-0
0904-1988

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
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POVIDONES	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fb1b88cc-c8d9-4efd-a137-d1b04440fbc0			1d3f2e2b-2600-4bdc-8653-59f3909f1031	2020-05-19	Warnings	Exact identifier spl set id: 1d3f2e2b-2600-4bdc-8653-59f3909f1031

Reported adverse events (FAERS/openFDA)#

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