NDC 0121-2823 Acetaminophen
Suspension Oral

Product Information

What is NDC 0121-2823?

The NDC code 0121-2823 is assigned by the FDA to the UNFINISHED product Acetaminophen which is a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0121-2823-94 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 20.3 ml in 1 cup, unit-dose (0121-2823-21). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0121-2823
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Acetaminophen
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Acetaminophen
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Acetaminophen
Product Type 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.		Human Otc Drug
Dosage FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.		Pharmaceutical Associates, Inc.
Labeler Code0121
FDA Application Number 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.		part343
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		09-03-2021
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Acetaminophen?


Product Characteristics

Color(s)PURPLE (C48327)
Flavor(s)GRAPE (C73391)

Product Packages

NDC Code 0121-2823-94

Package Description: 3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-2823-21)

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Acetaminophen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 650 mg/20.3mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Acetaminophen Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Acetaminophen Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Acetaminophen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free


Active Ingredient (In Each 5 Ml)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • 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.


Sore Throat Warning



If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


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 have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor



Ask a doctor before use if the user has liver disease


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin


Otc - When Using



When using this product do not exceed recommended dose (see overdose warning)


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

    • do not give this product to children for the pain of arthritis unless directed by a doctor

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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



  • Use as directed per healthcare professional.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not take more than 5 times in 24 hours
    • Weight (lb)Age (yr)Dose (mL)

    or as directed by a doctor

    Under 24Under 2 yearsask a doctor
    24-352-3 years5 mL
    36-474-5 years7.5 mL
    48-596-8 years10 mL
    60-719-10 years12.5 mL
    72-9511 years15 mL
    Over 96adults and children 12 years and over20 mL

Other Information



  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients



acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.


How Supplied



  • grape flavored suspension supplied in the following oral dosage forms:

    • NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups.

    NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups.

    NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.


Otc - Questions



Call 1-800-845-8210.


Manufactured By



Pharmaceutical Associates, Inc.

Greenville, SC 29860

www.paipharma.com


Principal Display Panel - 5 Ml Cup Label



NDC 0121-0941-05

ACETAMINOPHEN ORAL SUSPENSION

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 01

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 01


Principal Display Panel - 10.15 Ml Cup Label



NDC 0121-1882-11

ACETAMINOPHEN ORAL SUSPENSION

325 mg per 10.15 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 02

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 02


Principal Display Panel - 20.3 Ml Cup Label



NDC 0121-2823-21

ACETAMINOPHEN ORAL SUSPENSION

650 mg per 20.3 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 03

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - acetaminophen 03


* Please review the disclaimer below.