Flaxendol Extra Strength Acetaminophen
Acetaminophen
Gelpharma S.a. De C.v.
Human Otc Drug
NDC 69377-002Flaxendol Extra Strength Acetaminophen also known as Acetaminophen is a human otc drug labeled by 'Gelpharma S.a. De C.v.'. National Drug Code (NDC) number for Flaxendol Extra Strength Acetaminophen is 69377-002. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Flaxendol Extra Strength Acetaminophen drug includes Acetaminophen - 500 mg/1 . The currest status of Flaxendol Extra Strength Acetaminophen drug is Active.
Drug Information:
| Drug NDC: | 69377-002 |
| 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: | Flaxendol Extra Strength 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: | Gelpharma S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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: | 01 Jul, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | 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: | Gelpharma S.A. de C.V.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198439
|
| 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 |
|---|
| 69377-002-01 | 1 BOTTLE in 1 CARTON (69377-002-01) / 24 CAPSULE in 1 BOTTLE | 01 Jul, 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:
Purpose pain reliever/fever reducer
Product Elements:
Flaxendol extra strength acetaminophen acetaminophen fd&c red no. 40 gelatin glycerin polyethylene glycol 400 polyethylene glycol 600 silicon dioxide titanium dioxide water acetaminophen acetaminophen 27
Indications and Usage:
Uses for the temporary relief of minor aches and pains associated with the common cold headache toothache muscular aches backache premenstrual and menstrual the minor pain from arthritis to reduce fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage mayoccur if you take: more than 8 softgel capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse
Read more..., if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor stop using and ask a doctor if pain gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms prompt 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 liver warning: this product contains acetaminophen. severe liver damage mayoccur if you take: more than 8 softgel capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor stop using and ask a doctor if pain gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product do not exceed recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
Dosage and Administration:
Directions adults and children 12 years and over: take 2 capsules every 6 hours while symptoms last. do not take more than 6 capsules in 24 hours unless directed by a doctor. children under 12 years of age: consult a doctor.
Stop Use:
Stop using and ask a doctor if pain gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur
Package Label Principal Display Panel:
Package labeling: outer package inner package
Further Questions:
Questions or comments? (346) 326-1728 mon-fri 8:00a.m. est to 5:00p.m. est