Aspirin Enteric Coated

Aspirin 325 Mg

Allegiant Health
Human Otc Drug
NDC 69168-400

Aspirin Enteric Coated also known as Aspirin 325 Mg is a human otc drug labeled by 'Allegiant Health'. National Drug Code (NDC) number for Aspirin Enteric Coated is 69168-400. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Aspirin Enteric Coated drug includes Aspirin - 325 mg/1 . The currest status of Aspirin Enteric Coated drug is Active.

Drug Information:

Drug NDC:	69168-400
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Aspirin Enteric Coated
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Aspirin
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Enteric Coated
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Aspirin 325 Mg
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Allegiant Health
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ASPIRIN - 325 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	18 Dec, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Mar, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part343
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.
Listing Expiration Date:	16 Jan, 2025
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Allegiant Health
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198467
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0369168400306
UPC stands for Universal Product Code.
NUI:	N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	R16CO5Y76E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Cyclooxygenase Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Nonsteroidal Anti-inflammatory Drug [EPC] Platelet Aggregation Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Decreased Prostaglandin Production [PE] Decreased Platelet Aggregation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Anti-Inflammatory Agents, Non-Steroidal [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Anti-Inflammatory Agents Non-Steroidal [CS] Cyclooxygenase Inhibitors [MoA] Decreased Platelet Aggregation [PE] Decreased Prostaglandin Production [PE] Nonsteroidal Anti-inflammatory Drug [EPC] Platelet Aggregation Inhibitor [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
69168-400-17	300 TABLET in 1 BOTTLE (69168-400-17)	03 Jan, 2022	31 Mar, 2024	No
69168-400-30	1 BOTTLE in 1 CARTON (69168-400-30) / 30 TABLET in 1 BOTTLE	18 Dec, 2014	31 Mar, 2024	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Aspirin

Aspirin 325 Mg

Tablet
Allegiant Health
NDC: 69168-312

Aspirin Enteric Coated

Aspirin 325 Mg

Tablet
Allegiant Health
NDC: 69168-400

Purpose:

Purpose pain reliever

Product Elements:

Aspirin enteric coated aspirin 325 mg aspirin aspirin starch, corn croscarmellose sodium d&c yellow no. 10 aluminum oxide polysorbate 80 fd&c yellow no. 6 dimethicone triethyl citrate sodium hydroxide sodium lauryl sulfate talc titanium dioxide hypromelloses cellulose, microcrystalline mineral oil methacrylic acid - methyl methacrylate copolymer (1:1) t

Indications and Usage:

Uses for the temporary relief of minor aches and pains due to: headache toothache muscle pain minor arthritis pain menstrual pain colds or as recommended by a doctor

Warnings:

ain reliever/fever reducer 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 ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better an allergic reaction occurs. seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days these could be signs of a serious condition. 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Do Not Use:

Warnings reyes syndrome: 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 reyes syndrome, a rare but serious illness. allergy alert : aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock. 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 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 if you are allergic to aspirinor any other pain reliever/fever reducer 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 ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better an allergic reaction occurs. seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days these could be signs of a serious condition. 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Dosage and Administration:

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Stop Use:

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better an allergic reaction occurs. seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days these could be signs of a serious condition. 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Package Label Principal Display Panel:

Package/label principal display panel aspirin aspirin 325mg orange aspirin aspirin 325mg orange

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.