Acetaminophen

Manufacturer: Bonita Pharmaceuticals LLC
Effective date: 2013-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:06

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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.

Dosage and administration

Do not take more than directed (see overdose warning) Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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

Do not use if imprinted safety seal under cap is broken or missing Store at room temperature

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(855) 729-7200

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Acetaminophen 500mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

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

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 you have

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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 pressent

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours unless directed by a doctor
do not take for more than 10 days unless directed by a doctor

Children under 12years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Do not use if imprinted safety seal under cap is broken or missing
Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Povidone
Pregelatinized Starch
Sodium Starch Glycolate
Stearic Acid

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Acetaminophen 500mg, 1000ct caplets

Image 1 : Extra Strength Acetaminophen 500mg, 1000ct caplets

Extra Strength Acetaminophen 500mg, 100ct caplets

Image 2 : Extra Strength Acetaminophen 500mg, 100ct caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	1
198440	acetaminophen 500 MG Oral Tablet	SCD	1
198440	APAP 500 MG Oral Tablet	SY	1

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0353598003015	GTIN-13: 0353598003015 EAN-13: 0353598003015 GTIN-12: 353598003015 UPC-A: 353598003015 GTIN storage (14 digits): 00353598003015	Extra Strength Acetaminophen 500mg, 100ct caplets.jpg
Barcode	EAN-13	0353598003107	GTIN-13: 0353598003107 EAN-13: 0353598003107 GTIN-12: 353598003107 UPC-A: 353598003107 GTIN storage (14 digits): 00353598003107	Extra Strength Acetaminophen 500mg, 1000ct caplets.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53598-003-01	2019-11-27	C162847	48780-1	9855d018-e6a8-cd31-e053-dbdaa90ab51a	Extra Strength Acetaminophen 500mg Caplets
53598-003-10	2019-11-27	C162847	48780-1	9855d018-e6a8-cd31-e053-dbdaa90ab51a	Extra Strength Acetaminophen 500mg Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53598-003-01	Acetaminophen	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		1
53598-003-10	Acetaminophen	1000 in 1 BOTTLE, PLASTIC	TABLET, COATED	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53598-003	ACETAMINOPHEN TABLET, COATED [BONITA PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20130402_9a4c1908-93dc-4f73-aea6-d24cb862938a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

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

Acetaminophen
POVIDONE
STARCH, PREGELATINIZED CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53598-003	53598-003-01, 53598-003-10

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	FZ989GH94E	IACT
STARCH, PREGELATINIZED CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED PELLETS / ORAL	10.03 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 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
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		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
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 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
POVIDONE	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 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	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 30 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 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
c86191d5-b44f-4440-bd05-3aad8d90413b			9a4c1908-93dc-4f73-aea6-d24cb862938a	2013-04-02	Warnings	Exact identifier spl id: c86191d5-b44f-4440-bd05-3aad8d90413b spl set id: 9a4c1908-93dc-4f73-aea6-d24cb862938a

Reported adverse events (FAERS/openFDA)#

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