Acetaminophen
Kesin Pharma Corporation
Human Otc Drug
NDC 81033-002Acetaminophen is a human otc drug labeled by 'Kesin Pharma Corporation'. National Drug Code (NDC) number for Acetaminophen is 81033-002. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Acetaminophen drug includes Acetaminophen - 160 mg/5mL . The currest status of Acetaminophen drug is Active.
Drug Information:
| Drug NDC: | 81033-002 |
| 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: | 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: | Kesin Pharma Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - 160 mg/5mL
|
| 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: | 30 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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, 2024 |
| 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: | Kesin Pharma Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307675
|
| 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 |
|---|
| 81033-002-31 | 8 CARTON in 1 CASE (81033-002-31) / 30 CUP, UNIT-DOSE in 1 CARTON (81033-002-30) / 20.3 mL in 1 CUP, UNIT-DOSE (81033-002-20) | 30 Jun, 2021 | N/A | No |
| 81033-002-41 | 8 CARTON in 1 CASE (81033-002-41) / 40 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) / 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10) | 30 Jun, 2021 | N/A | No |
| 81033-002-51 | 8 CARTON in 1 CASE (81033-002-51) / 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-002-05) | 30 Jun, 2021 | 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 acetaminophen acetaminophen edetate disodium water sodium metabisulfite sorbitol sucralose sodium benzoate trisodium citrate dihydrate citric acid monohydrate glycerin polyethylene glycol, unspecified propylene glycol xanthan gum
Indications and Usage:
Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if adult takes more than more than 5 doses in in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years or age unless directed by physician. do not use ask a doctor before use ask a doctor before use if the user has liver disease. ask a doctor or pharmacist before use do no use with any other drug containing acetaminophen (
Read more...prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. if pregnant or breast-feeding, ask a health professional before use. stop use and ask a doctor if stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 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. keep out of reach of children. keep out of reach of children. overdose warning: 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 more than 5 doses in in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years or age unless directed by physician. do not use ask a doctor before use ask a doctor before use if the user has liver disease. ask a doctor or pharmacist before use do no 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 or pharmacist before use if the user is taking the blood thinning drug warfarin. if pregnant or breast-feeding, ask a health professional before use. stop use and ask a doctor if stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 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. keep out of reach of children. keep out of reach of children. overdose warning: 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 (see overdose warning) do not take more than 5 doses in any 24-hour period dose as follows or as directed by doctor: take only with dosing cup provided adults and children 12 years of age and older: 20 ml (640 mg) in dosing cup every 6 hours children under 12 years of age: ask a doctor this product does not contain directions or complete warnings for use
Stop Use:
Stop use and ask a doctor if stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 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 ndc 81033-002-05 acetaminophen oral solution 160mg/5ml delivers160mg/5ml store at 68° - 77° f lot exp pkg by kesin pharma phoenix, az alcohol, dye, sugar free ndc 81033-002-10 acetaminophen oral solution 160mg/5ml delivers 325mg/10.15ml store at 68° - 77° f lot exp pkg by kesin pharma phoenix, az alcohol, dye, sugar free ndc 81033-002-20 acetaminophen oral solution 160mg/5ml delivers 650mg/20.15ml store at 68° - 77° f lot exp pkg by kesin pharma phoenix, az alcohol, dye, sugar free 5ml container label 10.15ml container label 20.3ml container label
Further Questions:
Questions or comments? call 1-833-537-4679