Advil
Ibuprofen Sodium
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-0133Advil also known as Ibuprofen Sodium is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Advil is 0573-0133. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Advil drug includes Ibuprofen Sodium - 256 mg/1 . The currest status of Advil drug is Active.
Drug Information:
| Drug NDC: | 0573-0133 |
| 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: | 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 Sodium |
| 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 SODIUM - 256 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: | 08 Jul, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | NDA201803 |
| 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: | 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: | 153008 310965
|
| 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: | RM1CE97Z4N
|
| 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: | 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 |
|---|
| 0573-0133-01 | 3000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET | 11 Aug, 2014 | N/A | No |
| 0573-0133-02 | 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET | 08 Jul, 2013 | N/A | No |
| 0573-0133-04 | 2 PACKET in 1 BLISTER PACK (0573-0133-04) / 2 TABLET, COATED in 1 PACKET | 08 Jul, 2013 | N/A | No |
| 0573-0133-05 | 2 PACKET in 1 CARTON (0573-0133-05) / 2 TABLET, COATED in 1 PACKET | 08 Jul, 2013 | N/A | No |
| 0573-0133-20 | 1 BOTTLE in 1 CARTON (0573-0133-20) / 20 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-40 | 1 BOTTLE in 1 CARTON (0573-0133-40) / 40 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-41 | 1 BOTTLE in 1 CARTON (0573-0133-41) / 40 TABLET, COATED in 1 BOTTLE | 12 Aug, 2015 | N/A | No |
| 0573-0133-80 | 1 BOTTLE in 1 CARTON (0573-0133-80) / 80 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-81 | 1 BOTTLE in 1 CARTON (0573-0133-81) / 100 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-88 | 2 BOTTLE in 1 PACKAGE (0573-0133-88) / 120 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-89 | 1 BOTTLE in 1 CARTON (0573-0133-89) / 160 TABLET, COATED in 1 BOTTLE | 08 Jul, 2013 | N/A | No |
| 0573-0133-91 | 1 BOTTLE in 1 CARTON (0573-0133-91) / 180 TABLET, COATED in 1 BOTTLE | 01 Dec, 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:
Advil ibuprofen sodium ibuprofen sodium ibuprofen acesulfame potassium caramel carnauba wax silicon dioxide copovidone k25-31 ferric oxide red hypromellose, unspecified mannitol medium-chain triglycerides microcrystalline cellulose polyethylene glycol, unspecified propylene glycol sodium lauryl sulfate sucralose titanium dioxide beige advil;asymmetrical;underline advil ibuprofen sodium ibuprofen sodium ibuprofen acesulfame potassium caramel carnauba wax silicon dioxide copovidone k25-31 ferric oxide red hypromellose, unspecified mannitol medium-chain triglycerides microcrystalline cellulose polyethylene glycol, unspecified propylene glycol sodium lauryl sulfate sucralose titanium dioxide beige advil;asymmetrical;underline
Indications and Usage:
Uses ⢠temporarily relieves minor aches and pains due to: ⢠headache ⢠toothache ⢠backache ⢠menstrual cramps ⢠the common cold ⢠muscular aches ⢠minor pain of arthritis ⢠temporarily reduces fever
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 you: ⢠are age 60 or older ⢠have had stomach ulcers or bleeding problems ⢠take a blood thinning (anticoagulant) or steroid drug ⢠take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] ⢠have 3 or more alcoholic drinks every day while using this product ⢠take 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 highe
Read more...r if you use more than directed or for longer than directed. do not use ⢠if you have 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 you ⢠you have problems or serious side effects from taking pain relievers or fever reducers ⢠you have a history of stomach problems, such as heartburn ⢠you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ⢠you are taking a diuretic ask a doctor or pharmacist before use if you are ⢠under a doctor's care for any serious condition ⢠taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present in the painful area ⢠any new symptoms appear if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 you: ⢠are age 60 or older ⢠have had stomach ulcers or bleeding problems ⢠take a blood thinning (anticoagulant) or steroid drug ⢠take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] ⢠have 3 or more alcoholic drinks every day while using this product ⢠take 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. do not use ⢠if you have 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 you ⢠you have problems or serious side effects from taking pain relievers or fever reducers ⢠you have a history of stomach problems, such as heartburn ⢠you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ⢠you are taking a diuretic ask a doctor or pharmacist before use if you are ⢠under a doctor's care for any serious condition ⢠taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present in the painful area ⢠any new symptoms appear if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 ⢠do not take more than directed ⢠the smallest effective dose should be used ⢠adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist ⢠if pain or fever does not respond to 1 tablet, 2 tablets may be used ⢠do not exceed 6 tablets in 24 hours, unless directed by a doctor ⢠children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠pain gets worse or lasts more than 10 days ⢠fever 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 ndc 0573-0133-02 advil film-coated ibuprofen sodium ibuprofen tablets, 200 mg (provided as ibuprofen sodium 256 mg) pain reliever / fever reducer (nsaid) advil tablets ⢠headache ⢠muscular aches ⢠minor pain of arthritis ⢠menstrual cramps ⢠toothache ⢠fever see full drug facts information on the back of this dispenser 100 tablets (50 packets of 2 tablets each) 000068427 front carton advil ibuprofen tablets 100 ct
Principal display panel advil ® 20 free tablets ibuprofen tablets, 200 mg (provided as ibuprofen sodium 256 mg) pain reliever / fever reducer (nsaid) film-coated ibuprofen sodium advil tablets 100 tablets advil ibuprofen tablets 100 ct
Further Questions:
Questions or comments? call weekdays 9 am to 5 pm est at 1-800-88-advil