Aspirin 325
Aspirin
Walgreen Company
Human Otc Drug
NDC 0363-0691Aspirin 325 also known as Aspirin is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Aspirin 325 is 0363-0691. This drug is available in dosage form of Tablet, Delayed Release. The names of the active, medicinal ingredients in Aspirin 325 drug includes Aspirin - 325 mg/1 . The currest status of Aspirin 325 drug is Active.
Drug Information:
| Drug NDC: | 0363-0691 |
| 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 325 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Delayed Release |
| 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 NOT 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: | 01 Jul, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Walgreen Company
|
| 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: | 0311917193175
|
| 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 |
|---|
| 0363-0691-12 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0691-12) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 01 Jul, 2017 | N/A | 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. |
Purpose:
Purpose pain reliever
Product Elements:
Aspirin 325 aspirin aspirin aspirin powdered cellulose silicon dioxide starch, corn d&c yellow no. 10 fd&c yellow no. 6 hypromellose, unspecified methacrylic acid polydextrose polyethylene glycol, unspecified shellac dimethicone water sodium bicarbonate sodium lauryl sulfate talc titanium dioxide triacetin triethyl citrate 691
Indications and Usage:
Uses for the temporary relief of minor aches and pains or as recommended by your doctor. because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Warnings:
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 reye's syndrome, a rare but serious illness. allergy alert: aspirin may cause a severe allergic reaction, which may include: shock hives facial swelling asthma (wheezing) stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] are age 60 or older take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product do not use if you are allergic to aspirin or any other pain reliever/fev
Read more...er reducer if you have ever had an allergic reaction to this product or any of its ingredients 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 gout diabetes arthritis stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood feel faint have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
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 reye's syndrome, a rare but serious illness. allergy alert: aspirin may cause a severe allergic reaction, which may include: shock hives facial swelling asthma (wheezing) stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] are age 60 or older take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients 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 gout diabetes arthritis stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood feel faint have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 caplets every 4 hours not to exceed 12 caplets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor
Stop Use:
Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood feel faint have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel walgreens compare to the active ingredient in bayer® regular strength aspirin 325 mg safety coated caplets walgreens pharmacist recommended ndc 0363-0691-12 aspirin 325 325 mg / pain reliever (nsaid) regular strength enteric-coated actual size 100 caplets heart health** **talk to your doctor or other healthcare provider before using this product for your heart. tamper evident: do not use if imprinted safety seal under cap is broken or missing our pharmacists recommend the walgreens brand. we invite you to compare to national brands. this product is not manufactured or distributed by bayer ag, owner of the registered trademark bayer® regular strength aspirin 325 mg safety coated caplets. 50844 org012269112 distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens 100% satisfaction guaranteed walgreens.com ©2021 walgreen co. walgreens 44-691 walgreens 44-691
Further Questions:
Questions or comments? 1-800-426-9391