NDC 36800-557 Topcare Childrens Pain And Fever
Acetaminophen Suspension Oral

Product Information

Product Code36800-557
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.
Topcare Childrens Pain And Fever
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.
Topco Associates Llc
Labeler Code36800
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.
12-14-1993
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)RED (C48326 - OPAQUE)
Flavor(s)CHERRY (C73375)

Product Packages

NDC 36800-557-26

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

Product Details

Topcare Childrens Pain And Fever is a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Childrens Pain And Fever is acetaminophen. The product's dosage form is suspension and is administered via oral form.


What are Topcare Childrens Pain And Fever 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CALCIUM SULFATE (UNII: WAT0DDB505)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)


* Please review the disclaimer below.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Topcare Childrens Pain And Fever 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



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

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • •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 your child has ever had an allergic reaction to this product or any of its ingredients

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 dose (see overdose warning)


Stop Use And Ask A Doctor If



  • •pain gets worse or lasts more than 5 days
  • •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.


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 even if you do not notice any signs or symptoms.


Directions



  • •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 below. If possible, use weight to dose; otherwise, use age.
  • •remove the child protective cap and squeeze your child’s dose into the dosing cup
  • •repeat dose every 4 hours while symptoms last
  • •do not give more than 5 times in 24 hours
  • Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    36-47

    4-5 years

    7.5 mL

    48-59

    6-8 years

    10 mL

    60-71

    9-10 years

    12.5 mL

    72-95

    11 years

    15 mL

    *or as directed by a doctor

    •  Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information



  • •each 5 mL contains: sodium 3 mg
  • •store at 20-25°C (68-77°F)
  • •do not use if printed neckband is broken or missing
  • •see bottom panel for lot number and expiration date

Inactive Ingredients



anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate


Questions Or Comments?



1-888-423-0139


Principal Display Panel



ORAL SUSPENSION

For Ages 2 to 11 Years

Children’s

Pain & Fever

ACETAMINOPHEN

160 mg per 5 mL

Pain Reliever/Fever Reducer

Aspirin free

Ibuprofen free

Alcohol free

Fast, effective relief of children’s pain and fever

CHERRY FLAVOR

COMPARE TO CHILDREN’S TYLENOL® ORAL SUSPENSION active ingredient

4 FL OZ (118 mL)


* Please review the disclaimer below.