Dover Aminophen
Acetaminophen
Unifirst First Aid Corporation
Human Otc Drug
NDC 47682-303Dover Aminophen also known as Acetaminophen is a human otc drug labeled by 'Unifirst First Aid Corporation'. National Drug Code (NDC) number for Dover Aminophen is 47682-303. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Dover Aminophen drug includes Acetaminophen - 325 mg/1 . The currest status of Dover Aminophen drug is Active.
Drug Information:
| Drug NDC: | 47682-303 |
| 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 Aminophen |
| 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: | Acetaminophen |
| 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: | ACETAMINOPHEN - 325 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: | 30 Dec, 2008 |
| 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: | 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, 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: | 313782
|
| 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: | 0347682903336
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 47682-303-13 | 250 PACKET in 1 BOX (47682-303-13) / 2 TABLET, COATED in 1 PACKET (47682-303-99) | 30 Dec, 2008 | N/A | No |
| 47682-303-99 | 2 TABLET, COATED in 1 PACKET (47682-303-99) | 30 Dec, 2008 | 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 apap acetaminophen hypromelloses polyethylene glycol povidone sodium starch glycolate type a potato starch, corn stearic acid acetaminophen acetaminophen titanium dioxide white round az;234 medi-first non-aspirin acetaminophen sodium starch glycolate type a potato starch, corn stearic acid acetaminophen acetaminophen titanium dioxide hypromelloses polyethylene glycol povidone white round az;234 medi first plus non-aspirin acetaminophen hypromelloses polyethylene glycol povidone sodium starch glycolate type a potato starch, corn stearic acid acetaminophen acetaminophen titanium dioxide white round az;234 dover aminophen acetaminophen starch, corn stearic acid hypromelloses polyethylene glycol povidone sodium starch glycolate type a potato acetaminophen acetaminophen titanium dioxide white round az;234
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: headache muscular aches minor arthritis pain backache the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. 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 you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms
Read more... occur redness or swelling is present these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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 you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. 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 you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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.
Dosage and Administration:
Directions do not use more than directed (see overdose warning) â adults and children: (12 years and over) take 2 tablets every 4 to 6 hours while symptoms last. do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years: ask a doctor other information store at room temperature 59°-86°f (15°-30°c) tamper-evident sealed packets do not use any opened or torn packets
Stop Use:
Stop using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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.
Package Label Principal Display Panel:
Medique ® apap non-aspirin tablets tabletas sin aspirina pain reliever/fever reducer ⢠acetaminophen 325 mg alivia el dolor/reduce la fiebre ⢠acetaminofeno 325 mg this package is for households without young children este paquete es para hogares sin ninos pequenos pull to open tira para abrir 500 tablets (250 x 2) tamper evident unit dose packets empaquetado con sellado evidente en dosis unitarias medique
Medi-first ® non-aspirin aches, fever â acetaminophen 325 mg dolores, fiebre acetaminofeno 325 mg compare active ingredient to: tylenol® compare el ingredient active con: tylenol® registerd trademark of mcneil consumer products marca registrada de mcneil consumer products pull to open tira para abrir pain reliever/fever reducer alivia el dolor/reduce la fiebre this package is for households without young children este paquete es para hogares sin ninos pequenos tamper evident unit dose packets empaquetado con sellado evidente en dosis unitarias 500 tablets (250 x 2) medi-first
Mfp non-aspirin 325 mg label medi first ® plus non-aspirin acetaminophen 325mg pull to open this package is for households without young children pain reliever/fever reducer compare active ingredient to: tylenol® registered trademark of mcneil consumer tamper evident unit dose packets 100 tablets (50 x 2's) medi-first plus
Dover aminofen acetaminophen 325 mg pain reliever-fever reducer this package is for households withoutn 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 dover aminofen 1625303
Further Questions:
Questions or comments? 1-800-634-7680