Otis Clapp Mygrex
Acetaminophen, Phenylephrine Hydrochloride
Unifirst First Aid Corporation
Human Otc Drug
NDC 47682-148Otis Clapp Mygrex also known as Acetaminophen, Phenylephrine Hydrochloride is a human otc drug labeled by 'Unifirst First Aid Corporation'. National Drug Code (NDC) number for Otis Clapp Mygrex is 47682-148. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Otis Clapp Mygrex drug includes Acetaminophen - 500 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Otis Clapp Mygrex drug is Active.
Drug Information:
| Drug NDC: | 47682-148 |
| 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: | Otis Clapp Mygrex |
| 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, Phenylephrine Hydrochloride |
| 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 |
| 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 - 500 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 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 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: | 16 Jan, 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: | part341 |
| 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: | Unifirst First Aid Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1101534
|
| 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: | 0347682819484
0347682919337
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [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 |
|---|
| 47682-148-03 | 150 PACKET in 1 BOX (47682-148-03) / 2 TABLET in 1 PACKET (47682-148-99) | 30 Dec, 2008 | N/A | No |
| 47682-148-99 | 2 TABLET in 1 PACKET (47682-148-99) | 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 nasal decongestant
Product Elements:
Medi first sinus pain and pressure acetaminophen, phenylephrine hydrochloride stearic acid acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine cellulose, microcrystalline fd&c blue no. 1 povidone sodium starch glycolate type a corn starch, corn blue round fr;33 otis clapp mygrex acetaminophen, phenylephrine hydrochloride cellulose, microcrystalline fd&c blue no. 1 povidone sodium starch glycolate type a corn starch, corn stearic acid acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine blue round fr;33 medi first plus sinus pain and pressure acetaminophen, phenylephrine hydrochloride cellulose, microcrystalline fd&c blue no. 1 povidone sodium starch glycolate type a corn starch, corn stearic acid acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine blue round fr;33
Indications and Usage:
Uses temporarily relieves these common cold/flu symptoms: nasal congestion headache minor aches and pains stuffy nose sinus congestion and pressure temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for more than 10 days for pain unless directed by a doc
Read more...tor ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage. stop use and ask a doctor if you get nervous, dizzy, or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms appear 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 of acetaminophen in 24 hours 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 now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for more than 10 days for pain unless directed by a doctor ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage. stop use and ask a doctor if you get nervous, dizzy, or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms appear 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.
When Using:
When using this product do not exceed recommended dosage.
Dosage and Administration:
Directions do not use more than directed adults and children: (12 years and over) take 2 tablets every 6 hours. do not take more than 8 tablets in 24 hours. children under 12 years: ask adoctor
Stop Use:
Stop use and ask a doctor if you get nervous, dizzy, or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms appear these could be signs of a serious condition.
Package Label Principal Display Panel:
Medi-first plus sinus pain and pressure label 100 tablets (50 x 2's) medi first ® plus sinus pain and pressure aches & fever acetaminophen 500 mg nasal decongestant phenylephrine hcl 5 mg pull to open this package is for households without young children. sinus pain releif tamper evident unit dose packets medi-first
Medi-first sinus pain and pressure label 250 tablets (125 x 2) medi-first ® sinus pain and pressure alivio al dolor y presion en los senos nasales pull to open tire para abrir aches & fever acetaminophen 500 mg dolores, fiebre acetaminofeno 500 mg nasal decongestant phenylephrine hcl 5 mg descongestivo nasal hidrocloruro de fenilefrina 5 mg this package is for households without young children. este paquete es para hogares sin ninos pequenos. tamper evident unit dose packets empaquetado con sellado rvidente en dosis unitarias mf sinus
Otis clapp mygrex label otis clapp quality and integrity since 1840 mygrex pain reliever-decongestant advanced relief for sinus/headaches see warnings and directions on side panel this package is for households without young children. acetaminophen 500 mg aches & fever phenylephrine hcl 5 mg nasal decongestant tear out along perforation to dispense professional healthcare 300 tablets (150 packets of 2) otis
Further Questions:
Questions or comments? 1-800-634-7680