Medi-first Ibuprofen
Ibuprofen
Unifirst First Aid Corporation
Human Otc Drug
NDC 47682-608Medi-first Ibuprofen also known as Ibuprofen is a human otc drug labeled by 'Unifirst First Aid Corporation'. National Drug Code (NDC) number for Medi-first Ibuprofen is 47682-608. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Medi-first Ibuprofen drug includes Ibuprofen - 200 mg/1 . The currest status of Medi-first Ibuprofen drug is Active.
Drug Information:
| Drug NDC: | 47682-608 |
| 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: | Medi-first Ibuprofen |
| 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: | Unifirst First Aid Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film 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 - 200 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: | 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: | 01 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | ANDA075010 |
| 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: | Unifirst First Aid Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310965
900434
900438
|
| 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. |
| UPC: | 0347682808334
0347682908331
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 47682-608-13 | 250 PACKET in 1 BOX (47682-608-13) / 2 TABLET, FILM COATED in 1 PACKET | 26 Jan, 2017 | N/A | No |
| 47682-608-30 | 4 PACKET in 1 BOX (47682-608-30) / 2 TABLET, FILM COATED in 1 PACKET (47682-608-99) | 26 Jan, 2017 | N/A | No |
| 47682-608-33 | 50 PACKET in 1 BOX (47682-608-33) / 2 TABLET, FILM COATED in 1 PACKET | 26 Jan, 2017 | N/A | No |
| 47682-608-48 | 125 PACKET in 1 BOX (47682-608-48) / 2 TABLET, FILM COATED in 1 PACKET | 26 Jan, 2017 | N/A | No |
| 47682-608-50 | 25 PACKET in 1 BOX (47682-608-50) / 2 TABLET, FILM COATED in 1 PACKET | 01 Apr, 2019 | 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:
Medique iprin ibuprofen carnauba wax magnesium stearate sodium starch glycolate type a potato stearic acid titanium dioxide starch, corn hypromelloses silicon dioxide ferric oxide red lactose cellulose, microcrystalline polydextrose polyethylene glycol, unspecified ibuprofen ibuprofen 44;291 dover addaprin ibuprofen starch, corn silicon dioxide carnauba wax ferric oxide red magnesium stearate polydextrose polyethylene glycol, unspecified sodium starch glycolate type a potato stearic acid titanium dioxide cellulose, microcrystalline hypromelloses lactose ibuprofen ibuprofen 44;291 medi-first ibuprofen ibuprofen starch, corn ibuprofen ibuprofen carnauba wax ferric oxide red polyethylene glycol, unspecified silicon dioxide hypromelloses lactose magnesium stearate cellulose, microcrystalline polydextrose sodium starch glycolate type a potato stearic acid titanium dioxide 44;291 medi-first plus ibuprofen ibuprofen sodium starch glycolate type a potato carnauba wax ferric oxide red lactose cellulose, microcrystalline hypromelloses magnesium stearate polydextrose polyethylene glycol, unspecified starch, corn silicon dioxide stearic acid titanium dioxide ibuprofen ibuprofen 44;291 otis clapp ultraprin ibuprofen hypromelloses lactose magnesium stearate cellulose, microcrystalline polydextrose polyethylene glycol, unspecified sodium starch glycolate type a potato stearic acid titanium dioxide carnauba wax starch, corn silicon dioxide ferric oxide red ibuprofen ibuprofen 44;291
Indications and Usage:
Uses temporarily relieves minor aches and pains associated with â headache â toothache â backache â menstrual cramps â common cold â muscular aches â minor arthritis pain temporarily reduces fever.
Warnings:
Warnings allergy alert : ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: â hives â skin reddening â asthma (wheezing) â facial swelling â rash â shock â 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: â are age 60 or older â have had stomach ulcers or bleeding problems â take a blood thinning (anticoagulant) or steroid drug â take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â take more or for a longer time than directed heart attack or stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is high
Read more...er if you use more than directed or for longer than directed.
Do Not Use:
Warnings allergy alert : ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: â hives â skin reddening â asthma (wheezing) â facial swelling â rash â shock â 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: â are age 60 or older â have had stomach ulcers or bleeding problems â take a blood thinning (anticoagulant) or steroid drug â take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â take more or for a longer time than directed heart attack or 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.
When Using:
When using this product â take with food or milk if stomach upset occurs
Dosage and Administration:
Directions â do not use more than directed â the smallest effective dose should be used â do not take longer than 10 days, unless directed by a doctor (see warnings) adults and children: (12 years and older) 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 â you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better â you have symptoms of heart problems or stroke â chest pain â trouble breathing â weakness in one part or side of body â slurred speech â leg swelling â pain gets worse or lasts for more than 10 days â fever gets worse or lasts for more than 3 days â redness or swelling is present in the painful area â any new or unexpected symptoms occur
Package Label Principal Display Panel:
Medique iprin label medique® i-prin ibuprofen 200 mg anti-inflammatory (nsaid) this package is for households without young children. pull to open pain reliever/fever reducer ⢠ibuprofen 200 mg 200 tablets (100 x 2) tamper evident unit dose packets 100r iprin 10047
Medi-first ibuprofen label medi-first® ibuprofen 200 mg 100 tablets (50 x 2) pain reliever/fever reducer aches, fever ⢠ibuprofen (nsaid) 200mg pull to open compare active ingredient to: advil® registered trademark of pfizer consumer healthcare this package is for households without young children. tamper evident unit dose packets 100t mf ibuprofen
Medi-first plus ibuprofen label medi-first® plus ibuprofen 250 tablets (125 x 2âs) this package is for households without young children pull to open ibuprofen 200 mg (nsaid) pain reliever/fever reducer compare active ingredient to: advil® registered trademark of pfizer consumer healthcare tamper evident unit dose packets 100r mfp ibuprofen
Dover addaprin label âdover addaprin⢠pain reliever-fever reducer ibuprofen 200 mg tablets (nsaid) this package is for households without young children. dover pharmaceutical products of the highest quality and effectiveness tamper evident sealed packets unit dose packs 500 tablets (250 packets of 2) all dover pharmaceutical formulas conform to federal regulations antihistamine free no danger of drowsiness sugar free âfor safer use by diabetics salt free âminimizes high blood pressure caffeine free âavoides over stimulation 100r dover addaprin
Otis clapp ultraprin label oc otis clapp quality & integrity since 1840 ultraprin ⢠pain reliever-fever reducer (nsaid) ibuprofen tablets usp 200 mg for deep seated pain see warnings and directions on side panel tear out along perforation to dispense professional healthcare 500 tablets (250 packets of 2) otis clapp ultraprin label 1-31-19
Further Questions:
Questions or comments? 1-800-634-7680