Childrens Tukol Acetaminophen Fever Reducer Pain Reducer
Acetaminophen
Genomma Lab Usa, Inc.
Human Otc Drug
NDC 50066-525Childrens Tukol Acetaminophen Fever Reducer Pain Reducer also known as Acetaminophen is a human otc drug labeled by 'Genomma Lab Usa, Inc.'. National Drug Code (NDC) number for Childrens Tukol Acetaminophen Fever Reducer Pain Reducer is 50066-525. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Tukol Acetaminophen Fever Reducer Pain Reducer drug includes Acetaminophen - 160 mg/5mL . The currest status of Childrens Tukol Acetaminophen Fever Reducer Pain Reducer drug is Active.
Drug Information:
| Drug NDC: | 50066-525 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Childrens Tukol Acetaminophen Fever Reducer Pain Reducer |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Genomma Lab Usa, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 160 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 03 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part343 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Genomma Lab USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307668
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 362O9ITL9D
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50066-525-24 | 118 mL in 1 BOTTLE (50066-525-24) | 03 May, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose pain reliever/fever reducer
Product Elements:
Childrens tukol acetaminophen fever reducer pain reducer acetaminophen acetaminophen acetaminophen anhydrous citric acid butylparaben fd&c red no. 40 glycerin high fructose corn syrup microcrystalline cellulose carboxymethylcellulose sodium propylene glycol water sodium benzoate sorbitol sucralose xanthan gum
Indications and Usage:
Uses temporarily reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Warnings:
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:
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.
When Using:
When using this product do not exceed recommended dose (see overdose warning)
Dosage and Administration:
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
Stop Use:
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
Overdosage:
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.
Package Label Principal Display Panel:
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. aptapharmtukol feverpain 525 aptapharmtukol feverpain 525
Further Questions:
Questions? call 1-877-99-genom (43666)