Childrens Acetaminophen
Acetaminophen
Precision Dose Inc.
Human Otc Drug
NDC 68094-586Childrens Acetaminophen also known as Acetaminophen is a human otc drug labeled by 'Precision Dose Inc.'. National Drug Code (NDC) number for Childrens Acetaminophen is 68094-586. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Childrens Acetaminophen drug includes Acetaminophen - 160 mg/5mL . The currest status of Childrens Acetaminophen drug is Active.
Drug Information:
| Drug NDC: | 68094-586 |
| 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 Acetaminophen |
| 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: | Precision Dose Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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: | 30 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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: | Precision Dose 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. |
| 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 |
|---|
| 68094-586-58 | 50 BAG in 1 CASE (68094-586-58) / 1 SYRINGE, PLASTIC in 1 BAG / 2.5 mL in 1 SYRINGE, PLASTIC | 30 Jul, 2014 | 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 acetaminophen acetaminophen acetaminophen acetaminophen anhydrous citric acid butylparaben calcium sulfate, unspecified form carrageenan d&c red no. 33 fd&c blue no. 1 glycerin high fructose corn syrup microcrystalline cellulose carboxymethylcellulose sodium, unspecified propylene glycol water sodium benzoate sorbitol sodium phosphate, tribasic
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 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
Read more... 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.
Do Not Use:
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.
When Using:
When using this product do not exceed recommended dose (see overdose warning )
Dosage and Administration:
Directions use as directed per healthcare professional this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake cups well before using ml = milliliter find right dose on chart below. if possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours weight (lb) age (yr) dose (ml) or as directed by a doctor 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
Stop Use:
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.
Package Label Principal Display Panel:
Principal display panel - 2.5 ml syringe label children's acetaminophen oral suspension 80 mg / 2.5 ml delivers 2.5 ml store at 20°-25°c (68°-77°f) hospital use only alcohol free aspirin free gluten free ibuprofen free for oral use only principal display panel - 2.5 ml syringe label
Further Questions:
For inquiries call precision dose, inc. at 1-800-397-9228 or email druginfo@precisiondose.com