Aspirin EC Tablets, 81 mg

Manufacturer: Rebel Distributors Corp
Effective date: 2011-02-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:11

Label at a glance#

ProductAspirin EC

Active ingredientAspirin

Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Storage and handling

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact1-888-838-2872

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID¹)

nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug
under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

call 1-888-838-2872, weekdays, 8 AM-5 PM ET

SPL UNCLASSIFIED SECTION

Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960

Dist. 1993 0810REV 89 387R

Repackaged by: REBEL DISTRIBUTORS CORP, Thousand Oaks, CA 91320

TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer^® Low Dose.

PRINCIPAL DISPLAY PANEL - 81 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	1
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	1
308416	ASA 81 MG Delayed Release Oral Tablet	SY	1
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASPIRIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-684-00	2019-09-24	C162847	48780-1	934fe258-4acd-48b1-e053-8cdaa90a720a	Aspirin EC Tablets, 81 mg
21695-684-30	2019-09-24	C162847	48780-1	934fe258-4acd-48b1-e053-8cdaa90a720a	Aspirin EC Tablets, 81 mg
21695-684-72	2019-09-24	C162847	48780-1	934fe258-4acd-48b1-e053-8cdaa90a720a	Aspirin EC Tablets, 81 mg
21695-684-90	2019-09-24	C162847	48780-1	934fe258-4acd-48b1-e053-8cdaa90a720a	Aspirin EC Tablets, 81 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-684-00	Aspirin EC	100 in 1 BOTTLE	TABLET, COATED	100	1
21695-684-30	Aspirin EC	30 in 1 BOTTLE	TABLET, COATED	30	1
21695-684-72	Aspirin EC	120 in 1 BOTTLE	TABLET, COATED	120	1
21695-684-90	Aspirin EC	90 in 1 BOTTLE	TABLET, COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-684	ASPIRIN EC (ASPIRIN) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20110211_ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-684-00	EA - Each	21695-684	894246c9-c1d1-4319-8d3f-fd9bacfeb16d	1	2012-07-24
21695-684-30	EA - Each	21695-684	77bfaff0-d989-47ea-850b-bdb8deef742e	1	2012-07-24
21695-684-72	EA - Each	21695-684	7ca24109-4a1c-4faf-abe9-3baa06bfbf29	1	2012-07-24
21695-684-90	EA - Each	21695-684	60d8c65e-81db-461f-ab3c-fc268749d414	1	2012-07-24
0182-1061-05	EA - Each	0182-1061	4f2f3142-2b97-425f-940f-039cfd175a06	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Aspirin	ACTIVE INGREDIENT	R16CO5Y76E	1
Aspirin	ACTIVE MOIETY	R16CO5Y76E	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	1
D&C Yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Aspirin EC
Aspirin
anhydrous lactose
carnauba wax
silicon dioxide
croscarmellose sodium
D&C Yellow NO. 10
aluminum oxide
cellulose, microcrystalline
polysorbate 80
sodium hydroxide
sodium lauryl sulfate
talc
titanium dioxide
triethyl citrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-684	21695-684-30, 21695-684-90, 21695-684-00, 21695-684-72
0182-1061

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Aspirin	R16CO5Y76E	ACTIB
anhydrous lactose	3SY5LH9PMK	IACT
carnauba wax	R12CBM0EIZ	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
croscarmellose sodium	M28OL1HH48	IACT
D&C Yellow NO. 10	35SW5USQ3G	IACT
aluminum oxide	LMI26O6933	IACT
cellulose, microcrystalline	OP1R32D61U	IACT
polysorbate 80	6OZP39ZG8H	IACT
sodium hydroxide	55X04QC32I	IACT
sodium lauryl sulfate	368GB5141J	IACT
talc	7SEV7J4R1U	IACT
titanium dioxide	15FIX9V2JP	IACT
triethyl citrate	8Z96QXD6UM	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 10 · 552 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	SUSPENSION, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C Yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
D&C Yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / SUBLINGUAL	0.23 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TROCHE / ORAL		50 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
anhydrous lactose	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous lactose	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	GRANULE, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
anhydrous lactose	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE / ORAL		2490 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, CHEWABLE / ORAL		34 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
anhydrous lactose	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / SUBLINGUAL	128 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 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
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 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
ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b			ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b	2011-02-09	Warnings	Exact identifier spl id: ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b spl set id: ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b

Reported adverse events (FAERS/openFDA)#

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