NDC 50066-525 Childrens Tukol Acetaminophen Fever Reducer Pain Reducer

Acetaminophen

NDC Product Code 50066-525

NDC 50066-525-24

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer with NDC 50066-525 is a 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.

Labeler Name: Genomma Lab Usa, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer Active Ingredient(s)

What 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/5mL

Inactive Ingredient(s)

About 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.

  • 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)

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.

Labeler Name: Genomma Lab Usa, Inc.
Labeler Code: 50066
FDA Application Number: part343 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 05-03-2016 What 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: 12-31-2021 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

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 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

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

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarilyreduces feverrelieves minor aches and pains due to:the common coldfluheadachesore throattoothache

Warnings

  • Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takesmore than 5 doses in 24 hours which is the maxium daily amountwith other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 daysfever gets worse or lasts more tha 3 daysnew symptoms occurredness or swelling is presentThese 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 useShake well before using1mL = milliliter; tsp = teaspoonfulfind the right dose on chart below. If posssible, use weight to dose: otherwise use age.if needed, repeat dose every 4 hours while symptons lastdo not give more than 5 times in 24 hoursdo not give for more than 5 days unless directed by a doctorweight (lb)             age                             dose (mL or tsp)under  24              under 2 years              ask a doctor24 - 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 mgstore between 20-25°C (68-77°F )do not refrigeratekeep 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 SuspensionDO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSIONNEWAges 2 - 11Fever ReducerPain ReducerCHERRY FLAVOR4 FL OZ (118 mL)160 mg per 5 mLDistributer byGenomma Lab USA Inc.,Houston, TX 77027BX--058LOT No.Exp.

* Please review the disclaimer below.