Careone Infants Acetaminophen Suspension
NDC Package 41520-709-10

11-digit billing NDC: 41520070910
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Careone Infants Acetaminophen (acetaminophen) suspension is •this product does not contain directions or complete warnings for adult use•do not give more than directed (see overdose warning)•shake well before using•mL = milliliter•find right dose on chart. This formulation utilizes a suspension delivery system. Marketed by American Sales Company, this product is identified by NDC 41520-709 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
41520-709-10
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
41520-709
11-Digit Billing Format
41520070910
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Careone Infants Acetaminophen
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 160 mg/5mL
Usage Information
•this product does not contain directions or complete warnings for adult use•do not give more than directed (see overdose warning)•shake well before using•mL = milliliter•find right dose on chart. If possible, use weight to dose; otherwise, use age.•push air out of syringe. Insert syringe tip into bottle opening.•flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.•pull yellow part of syringe until it reaches and stays at the correct dose•dispense liquid slowly into child’s mouth, toward inner cheek•repeat dose every 4 hours while symptoms last•do not give more than 5 times in 24 hours•replace cap tightly to maintain child resistanceDosing ChartWeight (lb)Age (yr)Dose (mL)*under 24under 2 yearsask a doctor24-352-3 years5 mL* or as directed by a doctorAttention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
American Sales Company
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-14-2016
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 41520-709-10 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Careone Infants Acetaminophen, a human over the counter drug labeled by American Sales Company. This suspension is formulated for oral use and contains acetaminophen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by American Sales Company on December 14, 2016. The current certification is valid through December 31, 2027.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520070910. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
41520-709-10
11-Digit CMS (5-4-2)
41520-0709-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.