NDC 81033-002 Acetaminophen

Acetaminophen

NDC Product Code 81033-002

NDC 81033-002-31

Package Description: 8 CARTON in 1 CASE > 30 CUP, UNIT-DOSE in 1 CARTON (81033-002-30) > 20.3 mL in 1 CUP, UNIT-DOSE (81033-002-20)

NDC 81033-002-41

Package Description: 8 CARTON in 1 CASE > 40 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) > 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10)

NDC 81033-002-51

Package Description: 8 CARTON in 1 CASE > 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-50) > 5 mL in 1 CUP, UNIT-DOSE (81033-002-05)

NDC Product Information

Acetaminophen with NDC 81033-002 is a a human over the counter drug product labeled by Kesin Pharma Corporation. The generic name of Acetaminophen is acetaminophen. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307675.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Acetaminophen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kesin Pharma Corporation
Labeler Code: 81033
FDA Application Number: part343 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-30-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Acetaminophen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily:reduces feverrelieves minor aches and pains due to:the common coldfluheadachesore throattoothache

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 productchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has more alcoholic drinks everyday while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf 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.

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 ifsymptoms do not improvepain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese 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.

Directions

  • Do not take more than directed (see overdose warning)do not take more than 5 doses in any 24-hour perioddose as follows or as directed by doctor:take only with dosing cup providedadults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hourschildren under 12 years of age: ask a doctorthis product does not contain directions or complete warnings for use

Other Information

Each 5 mL contains:
sodium 8 mgstore at 20 -25°C (68 -77°F)tamper evident: DO NOT use if foil on cup is missing or tornAlcohol Free, Dye Free, Sugar Free

Inactive Ingredients

Citric acid, grape flavor[Ma1] , edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gumgrape flavor

* Please review the disclaimer below.