Twin Med - Procure Aspirin 81 mg Enteric Coated Tablets (55681-402)

Manufacturer: TWIN MED LLC
Effective date: 2025-06-05
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 20:37:15

Label at a glance#

ProductAspirin 81 mg

Active ingredientASPIRIN

Label structure15 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10

Aspirin Drug Facts

OTC - DO NOT USE SECTION

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

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.

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 becwause it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION

Pain reliever

OTC - STOP USE SECTION

Stop use and ask a doctor if - an allergic reaction occurs. Seek medical help right away. - you are experierance 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 - redness or swelling is present - new symptoms occur - ringing in the ears or a loss of hearing occurs. these could be signs of a serious condition.

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

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: 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 steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

OTHER SAFETY INFORMATION

Allergy Alert: Aspirin may cause a severe allergic reaction which may include: - hives - facial swelling - shock - asthma (wheezing)

INDICATIONS & USAGE SECTION

Pin Reliever

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55681-402-03

Procure - Adult Low Strength - Pain Reliever - Aspirin USP 81 mg (NSAID) Enteric Coated - 300 tablets - Compare to Active Ingredient in Aspirin Regimen BAYER®

Aspirin 300

Products#

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

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

Aspirin 81 mg
Aspirin Enteric Coated Tablets 81 mg
STEARIC ACID
POVIDONE
TRIETHYL CITRATE
SODIUM LAURYL SULFATE
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
SILICON DIOXIDE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
SODIUM BICARBONATE
TALC
D&C YELLOW NO. 10
ASPIRIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55681-402	55681-402-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STEARIC ACID	4ELV7Z65AP	IACT
POVIDONE	FZ989GH94E	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
STARCH, CORN	O8232NY3SJ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)	XRK36F13ZZ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
TALC	7SEV7J4R1U	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ASPIRIN	R16CO5Y76E	ACTIB

Source Document#

Source XML

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
47e2ca98-f7cb-c008-e063-6294a90a0819			f0390eef-22d9-134d-e053-2a95a90aa420	2026-01-08	Warnings	Exact identifier spl set id: f0390eef-22d9-134d-e053-2a95a90aa420

Reported adverse events (FAERS/openFDA)#

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