ACETAINOPHEN TABLETS USP 500 mg

Manufacturer: HIMPRIT PHARMACHEM PVT LTD
Effective date: 2010-07-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:25:16

Label at a glance#

ProductACETAMINOPHEN

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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

Storage and handling

* Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to :

headache
backache
the common cold
menstrual cramps

muscular aches
arthritis
toothache
reduces fever

Warnings

WARNINGS SECTION

Overdose Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.

Alcohol Warnings

SPL UNCLASSIFIED SECTION

If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

OTC - DO NOT USE SECTION

Do not use

with any other product containing acetaminophen

OTC - STOP USE SECTION

Stop use and Ask a doctor if

fever gets worse or lasts for more than 3 days
redness or swelling is present
pain gets worse or lasts for more than 10 days
new symptoms occur

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.

Direction

DOSAGE & ADMINISTRATION SECTION

do not use more that directed (see overdose warning)
adults and children 12 years and over : take 2 caplets every 6 hours as needed
do not take more than 8 caplets in 24 hours
Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN TABLETS USP 500 mg
Each Film coated Tablet Contains:
ACETAMINOPHEN 500 MG

Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-040-31

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	2
198440	acetaminophen 500 MG Oral Tablet	SCD	2
198440	APAP 500 MG Oral Tablet	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65437-040-31	2020-01-31	C162847	48780-1	9d75b9cf-f51b-f424-e053-dadaa90a57ce	ACETAINOPHEN TABLETS USP 500 mg
65437-040-50	2020-01-31	C162847	48780-1	9d75b9cf-f51b-f424-e053-dadaa90a57ce	ACETAINOPHEN TABLETS USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65437-040-31	ACETAMINOPHEN	1 in 1 DRUM	TABLET, FILM COATED	1	2
65437-040-31	ACETAMINOPHEN	31000 in 1 BAG	TABLET, FILM COATED	31000	2
65437-040-50	ACETAMINOPHEN	1 in 1 DRUM	TABLET, FILM COATED	1	2
65437-040-50	ACETAMINOPHEN	50000 in 1 BAG	TABLET, FILM COATED	50000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65437-040	ACETAMINOPHEN TABLET, FILM COATED [HIMPRIT PHARMACHEM PVT LTD]	2	Legacy NDC, 4 package rows	20100721_91f26af5-1d53-4e1a-8bbd-3af6c7571388.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

ACETAMINOPHEN
SODIUM METABISULFITE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL
STEARIC ACID
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65437-040	65437-040-31, 65437-040-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
SODIUM METABISULFITE	4VON5FNS3C	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	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 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOAP / TOPICAL	0.36 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CAPSULE / ORAL	0.36 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYSTEM / TOPICAL	0.5 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYSTEM / IONTOPHORESIS	0.5 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAVENOUS	27.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBMUCOSAL		5 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBMUCOSAL	5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBCUTANEOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / RECTAL	2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 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
dfdf9b9f-ecc3-4c25-8a5d-c744a9bb6651			91f26af5-1d53-4e1a-8bbd-3af6c7571388	2010-07-20	Warnings	Exact identifier spl id: dfdf9b9f-ecc3-4c25-8a5d-c744a9bb6651 spl set id: 91f26af5-1d53-4e1a-8bbd-3af6c7571388

Reported adverse events (FAERS/openFDA)#

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