® Tablets

® Tablets

Aspirin 81 mg by

Drug Labeling and Warnings

Aspirin 81 mg by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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®Tablets

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

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

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

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.

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.

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

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.

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

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

Pin Reliever

HOW SUPPLIED

Aspirin 81 mg (NSAID) Adult Low Strength Pain Reliever Enteric Coated

NDC: 63629-8893-1: 1000 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Aspirin 81 mg (NSAID) Adult Low Strength Pain Reliever Enteric Coated

Label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-8893(NDC: 71406-128)
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
TRIACETIN (UNII: XHX3C3X673)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TALC (UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

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: 63629-8893-1	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	05/03/2021	09/25/2024

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8893) , RELABEL(63629-8893)

Revised: 9/2024

Document Id: aa830fcd-5896-4f28-839f-a7866d585a12

Set id: 1993ef6e-fe7d-43d6-ac0c-620095b07b79

Version: 104

Effective Time: 20240925

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