Pain Reliever
Aspirin 81 Mg
Health Pharma Usa Llc
Human Otc Drug
NDC 71679-104Pain Reliever also known as Aspirin 81 Mg is a human otc drug labeled by 'Health Pharma Usa Llc'. National Drug Code (NDC) number for Pain Reliever is 71679-104. This drug is available in dosage form of Tablet, Delayed Release. The names of the active, medicinal ingredients in Pain Reliever drug includes Aspirin - 81 mg/1 . The currest status of Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 71679-104 |
| 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: | Pain Reliever |
| 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 81 Mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Health Pharma Usa Llc |
| 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 - 81 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: | 21 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | Health Pharma USA LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308416
|
| 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: | 0371679104109
|
| 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 |
|---|
| 71679-104-10 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71679-104-10) | 21 Jan, 2022 | 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:
Active ingredients (in each tablet) purpose aspirin 81 mg (nsaid)* ........................................ pain reliever *nonsteroidal anti-inflammatory drug
Product Elements:
Pain reliever aspirin 81 mg carnauba wax anhydrous lactose croscarmellose sodium d&c yellow no. 10 fd&c yellow no. 6 brown iron oxide methacrylic acid cellulose, microcrystalline polysorbate 80 dimethicone sodium hydroxide sodium lauryl sulfate titanium dioxide triethyl citrate aspirin aspirin silicon dioxide talc a1
Indications and Usage:
Uses 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. ask your doctor about other uses for 81 mg aspirin
Warnings:
Warnings reye's 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: hives shock facial swelling asthma (wheezing) 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 aspirin or any other pain reliever/fever r
Read more...educer ask a doctor before use if you have asthma 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 ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis under a doctor's care for any serious condition taking any other drug stop use and ask a doctor if you experience 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 an allergic reaction occurs. seek medical help right away. ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling present in the painful area new symptoms occur these could be sign 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 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 (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings reye's 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: hives shock facial swelling asthma (wheezing) 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 aspirin or any other pain reliever/fever reducer ask a doctor before use if you have asthma 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 ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis under a doctor's care for any serious condition taking any other drug stop use and ask a doctor if you experience 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 an allergic reaction occurs. seek medical help right away. ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling present in the painful area new symptoms occur these could be sign 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 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 (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage and Administration:
Directions 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
Stop Use:
Stop use and ask a doctor if you experience 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 an allergic reaction occurs. seek medical help right away. ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling present in the painful area new symptoms occur these could be sign of a serious condition
Package Label Principal Display Panel:
Principal display panel see new warnings information & directions compare to bayer® low dose aspirin active ingredients this product is not manufactured or distributed by bayer healthcare llc., owner of the registered trademark bayer® low dose aspirin. aspirin delayed release tablets, 81 mg 1000 count aspirin
Further Questions:
Questions or comments? call toll free 1-844-832-1138 monday through friday 9am 5pm est or www.health pharma.us