Pharbetol
Acetaminophen
Proficient Rx Lp
Human Otc Drug
NDC 71205-990Pharbetol also known as Acetaminophen is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Pharbetol is 71205-990. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Pharbetol drug includes Acetaminophen - 500 mg/1 . The currest status of Pharbetol drug is Active.
Drug Information:
| Drug NDC: | 71205-990 |
| 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: | Pharbetol |
| 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: | Proficient Rx Lp |
| 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: | 10 Jan, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UPC: | 0371205990008
|
| 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 |
|---|
| 71205-990-00 | 100 TABLET in 1 BOTTLE, PLASTIC (71205-990-00) | 01 Apr, 2020 | N/A | No |
| 71205-990-11 | 1000 TABLET in 1 BOTTLE, PLASTIC (71205-990-11) | 01 Apr, 2020 | N/A | No |
| 71205-990-50 | 50 TABLET in 1 BOTTLE, PLASTIC (71205-990-50) | 01 Apr, 2020 | N/A | No |
| 71205-990-55 | 500 TABLET in 1 BOTTLE, PLASTIC (71205-990-55) | 01 Apr, 2020 | 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:
Pharbetol acetaminophen acetaminophen acetaminophen povidone k30 starch, corn sodium starch glycolate type a potato stearic acid ph044
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: ⢠headache ⢠backache ⢠minor pain of arthritis ⢠toothache ⢠muscular aches ⢠menstrual cramps temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 8 tablets 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 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 ⢠if you are allergic to acetaminophen or any of the inactive ingredients in this product 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 stop use and ask a 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. if pregnant or breast-feeding, ask a health
Read more... professional before use. keep out of reach of children. overdose warning: taking more than the recommended dose (overdose) may cause liver damage. in the case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 8 tablets 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 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 ⢠if you are allergic to acetaminophen or any of the inactive ingredients in this product 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 stop use and ask a 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning: taking more than the recommended dose (overdose) may cause liver damage. in the case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning). ⢠adult and children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. do not take more than 8 tablets in 24 hours. do not take for more than 10 days unless directed by a doctor. ⢠children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
Stop Use:
Stop use and ask a 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.
Overdosage:
Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. in the case of overdose, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Ndc 71205-990-00 manufactured in the usa extra strength *compare to the active ingredient in extra strength tylenol caplet do not use any other product containing acetaminophen acetaminophen 500mg pain reliever fever reducer 100 tablets 71205-990-00
Further Questions:
Questions? adverse drug event call: (866) 562-2756 repackaged by: proficient rx lp thousand oaks, ca 91320