Junior Strength Advil
Ibuprofen
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-0175Junior Strength Advil also known as Ibuprofen is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Junior Strength Advil is 0573-0175. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Junior Strength Advil drug includes Ibuprofen - 100 mg/1 . The currest status of Junior Strength Advil drug is Active.
Drug Information:
| Drug NDC: | 0573-0175 |
| 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: | Junior Strength Advil |
| 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: | Ibuprofen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | IBUPROFEN - 100 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: | NDA |
| 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 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | NDA020267 |
| 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, 2024 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198405
731535
|
| 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. |
| NUI: | N0000000160
M0001335
N0000175722
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WK2XYI10QM
|
| 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. |
| Pharmacologic Class MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Drug [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0573-0175-11 | 1 BOTTLE in 1 CARTON (0573-0175-11) / 24 TABLET, COATED in 1 BOTTLE | 21 Jun, 2011 | 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 fever reducer/pain reliever
Product Elements:
Junior strength advil ibuprofen ibuprofen ibuprofen diacetylated monoglycerides carnauba wax silicon dioxide starch, corn croscarmellose sodium methylparaben microcrystalline cellulose shellac povidone, unspecified propylparaben sodium benzoate stearic acid sucrose ferric oxide red titanium dioxide tan round tablet advil;100
Indications and Usage:
Uses temporarily: ⢠reduces fever ⢠relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Warnings:
Warnings allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock ⢠skin reddening ⢠rash ⢠blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if the child ⢠has had stomach ulcers or bleeding problems ⢠takes a blood thinning (anticoagulant) or steroid drug ⢠takes other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] ⢠takes more or for a longer time than directed heart attack and stroke warning nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed. sore throat warning: severe or pe
Read more...rsistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult doctor promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. do not use ⢠if the child has ever had an allergic reaction to any other pain reliever/fever reducer ⢠right before or after heart surgery ask a doctor before use if ⢠stomach bleeding warning applies to the child ⢠child has problems or serious side effects from taking pain relievers or fever reducers ⢠child has a history of stomach problems, such as heartburn ⢠child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ⢠child has not been drinking fluids ⢠child has lost a lot of fluid due to vomiting or diarrhea ⢠child is taking a diuretic ask a doctor or pharmacist before use if the child is ⢠under a doctor's care for any serious condition ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠child experiences any of the following signs of stomach bleeding: ⢠feels faint ⢠vomits blood ⢠has bloody or black stools ⢠has stomach pain that does not get better ⢠child has symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠child does not get any relief within first day (24 hours) of treatment ⢠fever or pain gets worse or lasts more than 3 days ⢠redness or swelling is present in the painful area ⢠any new symptoms appear keep out of reach of children in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock ⢠skin reddening ⢠rash ⢠blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if the child ⢠has had stomach ulcers or bleeding problems ⢠takes a blood thinning (anticoagulant) or steroid drug ⢠takes other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] ⢠takes more or for a longer time than directed heart attack and stroke warning nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult doctor promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. do not use ⢠if the child has ever had an allergic reaction to any other pain reliever/fever reducer ⢠right before or after heart surgery ask a doctor before use if ⢠stomach bleeding warning applies to the child ⢠child has problems or serious side effects from taking pain relievers or fever reducers ⢠child has a history of stomach problems, such as heartburn ⢠child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ⢠child has not been drinking fluids ⢠child has lost a lot of fluid due to vomiting or diarrhea ⢠child is taking a diuretic ask a doctor or pharmacist before use if the child is ⢠under a doctor's care for any serious condition ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠child experiences any of the following signs of stomach bleeding: ⢠feels faint ⢠vomits blood ⢠has bloody or black stools ⢠has stomach pain that does not get better ⢠child has symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠child does not get any relief within first day (24 hours) of treatment ⢠fever or pain gets worse or lasts more than 3 days ⢠redness or swelling is present in the painful area ⢠any new symptoms appear keep out of reach of children in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product ⢠take with food or milk if stomach upset occurs
Dosage and Administration:
Directions ⢠this product does not contain directions or complete warnings for adult use ⢠do not give more than directed ⢠find right dose on chart below. if possible, use weight to dose; otherwise use age. ⢠repeat dose every 6-8 hours , if needed ⢠do not use more than 4 times a day dosing chart weight (lb) age (yr) dose (tablets) under 48 lb under 6 yr ask a doctor 48-71 lb 6-10 yr 2 tablets 72-95 lb 11 yr 3 tablets
Stop Use:
Stop use and ask a doctor if ⢠child experiences any of the following signs of stomach bleeding: ⢠feels faint ⢠vomits blood ⢠has bloody or black stools ⢠has stomach pain that does not get better ⢠child has symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠child does not get any relief within first day (24 hours) of treatment ⢠fever or pain gets worse or lasts more than 3 days ⢠redness or swelling is present in the painful area ⢠any new symptoms appear
Package Label Principal Display Panel:
Principal display panel junior strength advil ® ibuprofen tablets, 100 mg pain reliever/fever reducer (nsaid) fever aches & pains lasts up to 8 hours for ages 6-11 years 24 coated tablets principal display panel - 100 mg tablet bottle carton
Further Questions:
Questions or comments? call toll free 1-800-88-advil or ask your pharmacist, doctor or health care professional