Travel Savvy Non-aspirin
Acetaminophen 325mg
Bellegrove Medical Supply, Inc.
Human Otc Drug
NDC 59961-151Travel Savvy Non-aspirin also known as Acetaminophen 325mg is a human otc drug labeled by 'Bellegrove Medical Supply, Inc.'. National Drug Code (NDC) number for Travel Savvy Non-aspirin is 59961-151. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Travel Savvy Non-aspirin drug includes Acetaminophen - 325 mg/1 . The currest status of Travel Savvy Non-aspirin drug is Active.
Drug Information:
| Drug NDC: | 59961-151 |
| 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: | Travel Savvy Non-aspirin |
| 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 325mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bellegrove Medical Supply, Inc. |
| 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: | 13 Oct, 2014 |
| 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: | 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, 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: | Bellegrove Medical Supply, Inc.
|
| 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. |
| 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 |
|---|
| 59961-151-15 | 500 PACKET in 1 BOX (59961-151-15) / 2 TABLET, COATED in 1 PACKET | 13 Oct, 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:
Travel savvy non-aspirin acetaminophen 325mg acetaminophen acetaminophen starch, corn stearic acid titanium dioxide hypromelloses polyethylene glycol, unspecified povidone sodium starch glycolate type a potato az;234 travel savvy non-aspirin acetaminophen 325mg sodium starch glycolate type a potato starch, corn acetaminophen acetaminophen cellulose, microcrystalline hypromelloses polyethylene glycol, unspecified stearic acid povidone maltodextrin fr;2
Indications and Usage:
Uses for the temporary relief of minor aches and pains associated with headache common cold muscular aches toothache minor arthritis pain menstrual cramps for the reduction of fever.
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 12 tablets 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 symptoms do not improve new symptoms occur pain or fever persists or gets w
Read more...orse redness or swelling is present
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 12 tablets 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present
Dosage and Administration:
Directions do not use more than directed adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. do not take more than 12 tablets in 24 hours. children under 12 years: do not give to children under 12 years of age.
Stop Use:
Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present
Package Label Principal Display Panel:
Travel savvy non-aspirin label btravelsavvy.com travel savvy non-aspirin pain reliever fever reducer temporarily reduces fever and relieves minor aches and pains. 1000 tablets (500 x 2) belgrove
Travel savvy non-aspirin label btravelsavvy.com travel savvy non-aspirin pain reliever fever reducer temporarily reduces fever and relieves minor aches and pains. 1000 tablets (500 x 2) bg non
Further Questions:
Questions or comments? 1-800-323-1319