Childrens Pain And Fever Dissolve Packs
Acetaminophen
Walgreens Co.
Human Otc Drug
NDC 0363-5101Childrens Pain And Fever Dissolve Packs also known as Acetaminophen is a human otc drug labeled by 'Walgreens Co.'. National Drug Code (NDC) number for Childrens Pain And Fever Dissolve Packs is 0363-5101. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Childrens Pain And Fever Dissolve Packs drug includes Acetaminophen - 160 mg/1 . The currest status of Childrens Pain And Fever Dissolve Packs drug is Active.
Drug Information:
| Drug NDC: | 0363-5101 |
| 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 Pain And Fever Dissolve Packs |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Childrens Pain And Fever |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Dissolve Packs |
| 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: | Walgreens Co. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| 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/1
|
| 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: | 29 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | WALGREENS CO.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2178755
|
| 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 |
|---|
| 0363-5101-18 | 18 PACKET in 1 CARTON (0363-5101-18) / 1 POWDER in 1 PACKET | 29 Jan, 2020 | 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 pain and fever dissolve packs acetaminophen acetaminophen acetaminophen citric acid monohydrate gelatin, unspecified isomalt silicon dioxide sucralose off white
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 is allergic to acetaminophen or any of the inactive ingredients in this product 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 thinnin
Read more...g 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 for adults as well as 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. 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 is allergic to acetaminophen or any of the inactive ingredients in this product 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 for adults as well as for children 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 ? this product does not contain directions or complete warnings for adult use. ? do not give more than directed (see overdose warning ) ? find right dose on chart. if possible, use weight to dose; otherwise, use age. ? tear packet and pour powder on your child's tongue ? repeat dose every 4 hours while symptoms last ? do not give more than 5 times in 24 hours weight (lb) age (yrs.) dose (packets)** under 48 under 6 years do not use 48-59 6-8 years 2 packets 60-71 9-10 years 2 packets 72-95 11 years 3 packets
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 ndc 0363-5101-18 children's dye-free pain & fever dissolve packs acetaminophen 160 mg pain reliever/fever reducer dye free, aspirin free, ibuprofen free no water needed dissolves in seconds ages 6-11 years 18 packets* 160 mg each packet wild berry flavor naturally and artificially flavored *packets of powder pour powder on your childs tongue important: keep this carton for future reference on full labeling. walgreens pharmacist recommended walgreens pharmacist survey this product is not manufactured or distributed by mcneil consumer healthcare, distributor of the registered trademark childrens tylenol® dissolve packs. distributed by: walgreen co. 200 wilmot rd., ceerfield, il 60015 100% satisfaction guaranteed walgreens.com © 2020 walgreen co. walgreens dye-free pain and fever dissolve packs
Further Questions:
Questions? 1-866-467-2748