DailyMed - ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

NDC Code(s): 55681-402-03
Packager: TWIN MED LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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INACTIVE INGREDIENT

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
ACTIVE INGREDIENT

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug
ASK DOCTOR

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
ASK DOCTOR/PHARMACIST

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
Aspirin Drug Facts

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer
KEEP OUT OF REACH OF CHILDREN

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

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.
PURPOSE

Pain reliever
STOP USE

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

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

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

Pin Reliever
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®

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG
aspirin enteric coated tablets 81 mg tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55681-402
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

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

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	S17
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55681-402-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	11/01/2022

Labeler - TWIN MED LLC (009579330)

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Published Date (What is this?)	Version	Files
Jan 19, 2024	5 (current)	download
Jan 15, 2024	4	download
Dec 21, 2022	3	download

	RxCUI	RxNorm NAME	RxTTY
1	308416	aspirin 81 MG Delayed Release Oral Tablet	PSN
2	308416	aspirin 81 MG Delayed Release Oral Tablet	SCD
3	308416	ASA 81 MG Delayed Release Oral Tablet	SY
4	308416	aspirin 81 MG Enteric Coated Oral Tablet	SY

Label: ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

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Label: ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

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ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

Number of versions: 3

ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

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ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.