APINOPHEN

Manufacturer: A P J Laboratories Limited
Effective date: 2014-01-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:38:01

Label at a glance#

ProductAPINOPHEN EXTRA STRENGTH

Active ingredientACETAMINOPHEN

Label structure16 sections

Indications and uses

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches 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 swallow whole – do not crush, chew, or dissolve do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years : ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN 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.

uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

warning

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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

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
swallow whole – do not crush, chew, or dissolve
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under 12 years : ask a doctor

INACTIVE INGREDIENT SECTION

LACTOSE MONOHYDRATE

INACTIVE INGREDIENT SECTION

STARCH, CORN

INACTIVE INGREDIENT SECTION

GELATIN

INACTIVE INGREDIENT SECTION

METHYLPARABEN

INACTIVE INGREDIENT SECTION

PROPYLPARABEN

INACTIVE INGREDIENT SECTION

MAGNESIUM STEARATE

INACTIVE INGREDIENT SECTION

TALC

INACTIVE INGREDIENT SECTION

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT SECTION

SILICON DIOXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

productEnter section text here

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
46084-061-11	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-22	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-23	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-24	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-25	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-26	2019-11-27	C162847	48780-1	9855e2a2-4b0c-60a7-e053-dbdaa90a05bd	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46084-061-11	APINOPHENEXTRA STRENGTH	2 in 1 BLISTER PACK	TABLET	2	2
46084-061-22	APINOPHENEXTRA STRENGTH	60 in 1 BLISTER PACK	TABLET	60	2
46084-061-23	APINOPHENEXTRA STRENGTH	120 in 1 BLISTER PACK	TABLET	120	2
46084-061-24	APINOPHENEXTRA STRENGTH	250 in 1 BLISTER PACK	TABLET	250	2
46084-061-25	APINOPHENEXTRA STRENGTH	500 in 1 BLISTER PACK	TABLET	500	2
46084-061-26	APINOPHENEXTRA STRENGTH	100 in 1 BOTTLE	TABLET	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-061	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2	Legacy NDC, 6 package rows	20140103_c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

APINOPHEN EXTRA STRENGTH
ACETAMINOPHEN
LACTOSE MONOHYDRATE
STARCH, CORN
GELATIN
METHYLPARABEN
PROPYLPARABEN
MAGNESIUM STEARATE
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46084-061	46084-061-25, 46084-061-24, 46084-061-23, 46084-061-22, 46084-061-11, 46084-061-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
GELATIN	2G86QN327L	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TALC	7SEV7J4R1U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FOR SUSPENSION / ORAL		2794 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	107 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED / ORAL		300 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		520 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / INTRAVENOUS	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / SUBCUTANEOUS		98 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SOLUTION / ORAL	1691.8 mg/120ml		Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 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
5d9790ab-2120-4b04-a87c-d27e1e0640a2			c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d	2014-01-02	Warnings	Exact identifier spl id: 5d9790ab-2120-4b04-a87c-d27e1e0640a2 spl set id: c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d

Reported adverse events (FAERS/openFDA)#

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