NDC 36800-450 Childrens Pain And Fever

Acetaminophen

NDC Product Code 36800-450

NDC Code: 36800-450

Proprietary Name: Childrens Pain And Fever Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Acetaminophen Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
44;450
Score: 2
Flavor(s):
BUBBLE GUM (C73368)

Code Structure
  • 36800 - Topco Associates, Llc
    • 36800-450 - Childrens Pain And Fever

NDC 36800-450-08

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Childrens Pain And Fever with NDC 36800-450 is a a human over the counter drug product labeled by Topco Associates, Llc. The generic name of Childrens Pain And Fever is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Topco Associates, Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Childrens Pain And Fever Active Ingredient(s)

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

  • ACETAMINOPHEN 160 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Topco Associates, Llc
Labeler Code: 36800
FDA Application Number: part343 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-15-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Childrens Pain And Fever Product Label Images

Childrens Pain And Fever 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 Ingredient (In Each Chewable Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headache sore throat flutoothache  the common coldtemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takesmore than 5 doses in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddening blisters rashIf 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If Your Child Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

Taking the blood thinning drug warfarin.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • Pain 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult usedo not give more than directedfind the right dose on chart below. If possible, use weight to dose; otherwise, use age.chew or crush tablets completely before swallowing; do not swallow tablets wholerepeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo not give for more than 5 days unless directed by a doctorWeight (lb)  Age (yr) Dose (chewable tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-9511 3 tablets

Other Information

  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)avoid high humiditysee end flap for expiration date and lot number

Inactive Ingredients

Citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

* Please review the disclaimer below.

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