Fever Reducing Childrens
Acetaminophen
Cvs Pharmacy
Human Otc Drug
NDC 59779-579Fever Reducing Childrens also known as Acetaminophen is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Fever Reducing Childrens is 59779-579. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Fever Reducing Childrens drug includes Acetaminophen - 120 mg/1 . The currest status of Fever Reducing Childrens drug is Active.
Drug Information:
| Drug NDC: | 59779-579 |
| 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: | Fever Reducing Childrens |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Fever Reducing |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | childrens |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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 - 120 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| 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: | ANDA |
| 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: | 21 Jan, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | ANDA070607 |
| 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198434
|
| 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 |
|---|
| 59779-579-53 | 12 BLISTER PACK in 1 CARTON (59779-579-53) / 1 SUPPOSITORY in 1 BLISTER PACK | 21 Jan, 2010 | 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:
Purposes pain reliever/fever reducer
Product Elements:
Fever reducing childrens acetaminophen acetaminophen acetaminophen cottonseed oil
Indications and Usage:
Uses temporarily ⢠reduces fever ⢠relieves minor aches, pains, and headache
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. for rectal use only do not use ⢠if you are allergic to acetaminophen ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if ⢠your child has liver disease ⢠your child is taking the blood thinning drug warfarin stop use and ask a doctor if ⢠fever lasts more than 3 days (72 hours), or recurs. ⢠pain lasts more than 5 days or gets worse. ⢠new symptoms occur. ⢠redness or swelling
Read more... is present in the painful area. these may be signs of a serious condition. keep out of reach of children. if swallowed or in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick medical attention is critical in case of overdose for adults and for children 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. for rectal use only do not use ⢠if you are allergic to acetaminophen ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if ⢠your child has liver disease ⢠your child is taking the blood thinning drug warfarin stop use and ask a doctor if ⢠fever lasts more than 3 days (72 hours), or recurs. ⢠pain lasts more than 5 days or gets worse. ⢠new symptoms occur. ⢠redness or swelling is present in the painful area. these may be signs of a serious condition. keep out of reach of children. if swallowed or in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
Dosage and Administration:
Directions ⢠this product does not contain directions or warnings for adult use ⢠do not use more than directed ⢠remove wrapper ⢠carefully insert suppository well up into the rectum dosing chart age dose under 3 years do not use unless directed by a doctor 3 to 6 years use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Stop Use:
Stop use and ask a doctor if ⢠fever lasts more than 3 days (72 hours), or recurs. ⢠pain lasts more than 5 days or gets worse. ⢠new symptoms occur. ⢠redness or swelling is present in the painful area. these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in feverall ® for children fever reducing suppositories acetaminophen suppositories 120 mg pain reliever; fever reducer ages 3-6 years actual size 12 rectal suppositories, 120 mg each fever reducing suppositories image
Further Questions:
Questions or comments? 1-800-719-9260