NDC 50066-525 Childrens Tukol Acetaminophen Fever Reducer Pain Reducer
Acetaminophen Liquid Oral

Product Information

Product Code50066-525
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 Tukol Acetaminophen Fever Reducer Pain Reducer
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Genomma Lab Usa, Inc.
Labeler Code50066
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.
05-03-2016
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.
12-31-2022
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

Flavor(s)CHERRY (C73375)

Product Packages

NDC 50066-525-24

Package Description: 118 mL in 1 BOTTLE

Product Details

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer is a human over the counter drug product labeled by Genomma Lab Usa, Inc.. The generic name of Childrens Tukol Acetaminophen Fever Reducer Pain Reducer is acetaminophen. The product's dosage form is liquid and is administered via oral form.


What are Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)


* 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.

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 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



Drug Factsactive Ingredient(In Each 5 Ml = 1 Teaspoonful)



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 cantains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours which is the maxium daily amount
  • with other drugs containing acetaminophen
  • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.


Do Not Use



  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug containd acetaminophen, ask a doctor or pharmacist

Ask A Doctor Before Use If The Child Has



liver disease


Ask A Doctor Or Pharmacist Before Use If The 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 tha 3 days
  • new symptoms occur
  • redness or swelling is present
  • These could be signs of a serious condition


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 (1-800-222-1222) right away.
Quick medical attention is critical even if you do not notice any signs or symptoms.


Directions *



  • product is not labeled with directions or complete warning for adult use
  • Shake well before using
  • 1mL = milliliter; tsp = teaspoonful
  • find the right dose on chart below. If posssible, use weight to dose: otherwise use age.
  • if needed, repeat dose every 4 hours while symptons last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • weight (lb)             age                             dose (mL or tsp)

    under  24              under 2 years              ask a doctor

    24 - 35                  2 - 3 years                  5 mL (1 tsp)

    36- 47                   4 - 5 years                   7.5 mL (1 1/2 tsp)

    48 - 59                  6 - 8 years                  10 mL (10 mL (2 tsp)

    60- 71                   9 - 10 years                 12.5 mg  (2 1/2 tsp)

    72 95                    11 years                       15 mL (3 tsp)

    use only enclosed dosing cup specfically designed for use with this product


Attention:



use only enclosed dosing cup specfically designed for use with this product


Other Information



  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F )
  • do not refrigerate
  • keep carton for complete Drug facts

Inactive Ingredients



anhydrous citric acid, butylparaben, FD&C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions?



Call 1-877-99-GENOM (43666)


Children's Tukol® Fever Pain Product Label



Children's Tukol®

Acetaminophen - Pain Reliever-Fever Reducer Oral Suspension

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSION

NEW

Ages 2 - 11

Fever Reducer

Pain Reducer

CHERRY FLAVOR

4 FL OZ (118 mL)
160 mg per 5 mL

Distributer by
Genomma Lab USA Inc.,
Houston, TX 77027

BX--058

LOT No.

Exp.


* Please review the disclaimer below.