Acetaminophen Pain Reliever,fever Reducer
Acetaminophen
Nucare Pharmaceuticals,inc.
Human Otc Drug
NDC 68071-4118Acetaminophen Pain Reliever,fever Reducer also known as Acetaminophen is a human otc drug labeled by 'Nucare Pharmaceuticals,inc.'. National Drug Code (NDC) number for Acetaminophen Pain Reliever,fever Reducer is 68071-4118. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Acetaminophen Pain Reliever,fever Reducer drug includes Acetaminophen - 325 mg/1 . The currest status of Acetaminophen Pain Reliever,fever Reducer drug is Active.
Drug Information:
| Drug NDC: | 68071-4118 |
| 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 Pain Reliever,fever Reducer |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Acetaminophen |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Pain Reliever,Fever Reducer |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Nucare Pharmaceuticals,inc. |
| 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 - 325 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: | 27 Mar, 2006 |
| 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: | NuCare Pharmaceuticals,Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313782
|
| 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. |
| UPC: | 0368071411836
|
| 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 |
|---|
| 68071-4118-2 | 20 TABLET in 1 BOTTLE (68071-4118-2) | 13 Oct, 2017 | N/A | No |
| 68071-4118-3 | 30 TABLET in 1 BOTTLE (68071-4118-3) | 13 Oct, 2017 | N/A | No |
| 68071-4118-4 | 40 TABLET in 1 BOTTLE (68071-4118-4) | 13 Oct, 2017 | N/A | No |
| 68071-4118-5 | 25 TABLET in 1 BOTTLE (68071-4118-5) | 13 Oct, 2017 | N/A | No |
| 68071-4118-6 | 60 TABLET in 1 BOTTLE (68071-4118-6) | 13 Oct, 2017 | 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:
Purposes pain reliever/fever reducer
Product Elements:
Acetaminophen pain reliever,fever reducer acetaminophen povidone starch, corn sodium starch glycolate type a corn stearic acid acetaminophen acetaminophen round flat faced beveled edge gpi;a325
Indications and Usage:
Uses for the temporary relief of minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever.
Warnings:
Warnings liver warning : this product contains acetaminophen. severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 non prescription). 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 the user has liver disease. ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. stop use and ask a doctor if pain gets worse or lasts more than
Read more...10 days in adults and children pain gets worse or lasts more than 5 days in children under 12 years 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 case of overdose get medical help or contact a poison control center right away. (1-800-222-1222). 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 liver warning : this product contains acetaminophen. severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 non prescription). 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 the user has liver disease. ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults and children pain gets worse or lasts more than 5 days in children under 12 years 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 case of overdose get medical help or contact a poison control center right away. (1-800-222-1222). 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 do not take more than directed age dose adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours children 6 - 11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours children under 6 years do not use adult regular strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
Stop Use:
Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults and children pain gets worse or lasts more than 5 days in children under 12 years 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 case of overdose get medical help or contact a poison control center right away. (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel pdp
Further Questions:
Questions? if you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.