NDC 0121-0939 Childrens Acetaminophen
Acetaminophen Suspension Oral

Product Information

Product Code0121-0939
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.
Childrens 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
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.
01-29-2021
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
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325 - CLEAR, DYE-FREE)

Product Packages

NDC 0121-0939-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0939-05)

Product Details

Childrens Acetaminophen is a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Childrens Acetaminophen is acetaminophen. The product's dosage form is suspension and is administered via oral form.


What are Childrens Acetaminophen Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • XANTHAN GUM (UNII: TTV12P4NEE)


* Please review the disclaimer below.

Childrens Acetaminophen Labeling and Warnings

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.

Table of Contents



Other



Drug Facts

Manfactured By

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com


Liver Warning



This product contains acetaminophen. Severe liver damage may occur if

  • • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

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)


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.


Other Information



  •  each 5 mL contains: sodium: 2 mg
  •  Store at 20° to 25°C (68° to 77°F)
  •  berry flavored suspension supplied in the following oral dosage forms:
     NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.
     NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients



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


Otc - Questions



Call 1-800-845-8210.


Principal Display Panel - 5 Ml Cup Label



Delivers 5 mL

NDC 0121-0939-05

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION

160 mg per 5 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT


Principal Display Panel - 10 Ml Cup Label



Delivers 10 mL

NDC 0121-1878-10

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION 

320 mg per 10 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT


* Please review the disclaimer below.