Dover Addaprin
Ibuprofen
Unifirst First Aid Corporation
Human Otc Drug
NDC 47682-714Dover Addaprin also known as Ibuprofen is a human otc drug labeled by 'Unifirst First Aid Corporation'. National Drug Code (NDC) number for Dover Addaprin is 47682-714. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Dover Addaprin drug includes Ibuprofen - 200 mg/1 . The currest status of Dover Addaprin drug is Active.
Drug Information:
| Drug NDC: | 47682-714 |
| 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: | Dover Addaprin |
| 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, 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: | 26 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | ANDA079174 |
| 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 |
|---|
| 47682-714-13 | 250 PACKET in 1 BOX (47682-714-13) / 2 TABLET, COATED in 1 PACKET (47682-714-99) | 26 Jan, 2017 | 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:
Medi-first ibuprofen ibuprofen starch, corn povidone k30 stearic acid titanium dioxide sodium starch glycolate type a potato silicon dioxide ferric oxide red talc polyvinyl alcohol, unspecified polyethylene glycol, unspecified ibuprofen ibuprofen reddish brown g;2 medi-first plus ibuprofen ibuprofen povidone k30 sodium starch glycolate type a potato titanium dioxide stearic acid starch, corn talc ferric oxide red polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide ibuprofen ibuprofen g;2 reddish brown medique iprin ibuprofen starch, corn stearic acid titanium dioxide silicon dioxide povidone k30 ferric oxide red sodium starch glycolate type a potato polyvinyl alcohol, unspecified talc polyethylene glycol, unspecified ibuprofen ibuprofen reddish brown g;2 dover addaprin ibuprofen starch, corn titanium dioxide ferric oxide red stearic acid silicon dioxide povidone k30 sodium starch glycolate type a potato polyvinyl alcohol, unspecified polyethylene glycol, unspecified talc ibuprofen ibuprofen reddish brown g;2 otis clapp ultraprin ibuprofen polyethylene glycol, unspecified talc polyvinyl alcohol, unspecified silicon dioxide titanium dioxide stearic acid sodium starch glycolate type a potato povidone k30 starch, corn ferric oxide red ibuprofen ibuprofen reddish brown g;2
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 highe
Read more...r 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:
Medi-first ibuprofen label medi-first® ibuprofen 200 mg 100 tablets (50 x 2) pain reliever/fever reducer aches, fever ⢠ibuprofen (nsaid) 200 mg 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 100r mf ibuprofen
Medi-first plus ibuprofen label medi-first® plus ibuprofen ibuprofen 200 mg (nsaid) 100 tablets (50 x 2âs) pull to open this package isfor households without young children. pain reliever/fever reducer compare active ingredient to: advil® registered trademark of pfizer consumer healthcare tamper evident unit dose packets 100r mfp ibuprofen
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
Dover addaprin label dover addaprin⢠ibuprofen 200 mg tablets (nsaid) pain reliever-fever reducer 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) 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