Max Non Aspirin
Acetaminophen
Provision Medical Products
Human Otc Drug
NDC 69103-2522Max Non Aspirin also known as Acetaminophen is a human otc drug labeled by 'Provision Medical Products'. National Drug Code (NDC) number for Max Non Aspirin is 69103-2522. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Max Non Aspirin drug includes Acetaminophen - 500 mg/1 . The currest status of Max Non Aspirin drug is Active.
Drug Information:
| Drug NDC: | 69103-2522 |
| 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: | Max Non Aspirin |
| 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: | Acetaminophen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Provision Medical Products |
| 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: | ACETAMINOPHEN - 500 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: | 31 Mar, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Feb, 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: | 18 Jun, 2026 |
| 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: | Provision Medical Products
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198440
|
| 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: | 0858704004066
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69103-2522-5 | 250 PACKET in 1 CARTON (69103-2522-5) / 2 TABLET in 1 PACKET | 31 Mar, 2015 | 01 Feb, 2024 | No |
| 69103-2522-6 | 100 PACKET in 1 CARTON (69103-2522-6) / 2 TABLET in 1 PACKET | 31 Mar, 2015 | 01 Feb, 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. |
Purpose:
Pain reliever/fever reducer
Product Elements:
Max non aspirin acetaminophen povidone sodium starch glycolate type a corn starch, corn stearic acid acetaminophen acetaminophen snow white fr1
Indications and Usage:
Uses: for the temporary relief of minor aches and pains associated with: ⢠headache ⢠common cold ⢠toothache ⢠minor arthritis pains ⢠muscular aches ⢠menstrual cramps ⢠for the reduction of fever
Warnings:
Warnings: alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. acetaminophen may cause liver damage. do not use: ⢠with any other product containing acetaminophen ⢠for more than 10 days for pain unless directed by a doctor ⢠for more than 3 days for fever unless directed by a doctor stop using and ask a doctor if: ⢠symptoms do not improve ⢠new symptoms occur ⢠pain or fever persists or gets worse ⢠redness or swelling is present do not exceed recommended dosage
Dosage and Administration:
Directions: do not use more than directed adults and children 12 years and older take 2 tablets every 4 to 6 hours as needed. do not take more than 8 tablets in 24 hours, or as directed by a doctor. children under 12 years do not give to children under 12 years of age unless directed by a doctor.
Package Label Principal Display Panel:
Non asprin box