NDC 71406-128 Aspirin 81 Mg

Aspirin Enteric Coated Tablets 81 Mg

NDC Product Code 71406-128

NDC CODE: 71406-128

Proprietary Name: Aspirin 81 Mg What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspirin Enteric Coated Tablets 81 Mg What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
S;17

NDC Code Structure

NDC 71406-128-10

Package Description: 1000 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 71406-128-12

Package Description: 120 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Aspirin 81 Mg with NDC 71406-128 is a a human over the counter drug product labeled by Aace Pharmaceuticals, Inc.. The generic name of Aspirin 81 Mg is aspirin enteric coated tablets 81 mg. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Aace Pharmaceuticals, Inc.

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aspirin 81 Mg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASPIRIN 81 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aace Pharmaceuticals, Inc.
Labeler Code: 71406
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-03-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Aspirin 81 Mg Product Label Images

Aspirin 81 Mg Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

Otc - Active Ingredient

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

Otc - 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

Otc - 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

Otc - 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.

Otc - 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.

Otc - Purpose

Pain reliever

Otc - 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.

Other

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

* Please review the disclaimer below.