Acetaminophen
Geri-care Pharmaceutical Corp
Human Otc Drug
NDC 57896-268Acetaminophen is a human otc drug labeled by 'Geri-care Pharmaceutical Corp'. National Drug Code (NDC) number for Acetaminophen is 57896-268. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Acetaminophen drug includes Acetaminophen - 650 mg/1 . The currest status of Acetaminophen drug is Active.
Drug Information:
| Drug NDC: | 57896-268 |
| 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: | Acetaminophen |
| 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: | Geri-care Pharmaceutical Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Extended 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: | ACETAMINOPHEN - 650 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: | ANDA |
| 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, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | ANDA211544 |
| 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: | GERI-CARE PHARMACEUTICAL CORP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1148399
|
| 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. |
| 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 |
|---|
| 57896-268-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01) | 01 Jul, 2019 | 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/fever reducer
Product Elements:
Acetaminophen acetaminophen hydroxyethyl cellulose (140 mpa.s at 5%) hypromellose 2910 (6 mpa.s) magnesium stearate cellulose, microcrystalline polyethylene glycol 400 povidone k30 starch, corn sodium starch glycolate type a corn stearic acid acetaminophen acetaminophen g650
Indications and Usage:
Uses ⢠temporarily relieves minor aches and pains due to: ⢠minor pain of arthritis ⢠muscular aches ⢠backache ⢠premenstrual and menstrual cramps ⢠the common cold ⢠headache ⢠toothache ⢠temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 caplets in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks everyday while using this product allergy alert: acetaminophen may cause severe skin reactions symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 caplets in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks everyday while using this product allergy alert: acetaminophen may cause severe skin reactions symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) adults: ⢠take 2 caplets every 8 hours with water ⢠swallow whole; do not crush, chew, split or dissolve ⢠do not take more than 6 caplets in 24 hours ⢠do not use for more than 10 days unless directed by a doctor under 18 years of age: ask a doctor
Stop Use:
Stop use and ask doctor if ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel 1
Further Questions:
Questions or comments ? 1-800-540-3765