Percy Medicine
Bismuth Subsalicylate
Merrick Medicine Company, Inc
Human Otc Drug
NDC 0322-2222Percy Medicine also known as Bismuth Subsalicylate is a human otc drug labeled by 'Merrick Medicine Company, Inc'. National Drug Code (NDC) number for Percy Medicine is 0322-2222. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Percy Medicine drug includes Bismuth Subsalicylate - 1050 mg/10mL . The currest status of Percy Medicine drug is Active.
Drug Information:
| Drug NDC: | 0322-2222 |
| 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: | Percy Medicine |
| 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: | Bismuth Subsalicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Merrick Medicine Company, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | BISMUTH SUBSALICYLATE - 1050 mg/10mL
|
| 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: | 09 Sep, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | part335 |
| 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: | Merrick Medicine Company, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 616343
1233767
|
| 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. |
| NUI: | M0002611
N0000180183
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 62TEY51RR1
|
| 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 EPC: | Bismuth [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: | Bismuth [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]. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0322-2222-00 | 1 BOTTLE in 1 BOX (0322-2222-00) / 90 mL in 1 BOTTLE (0322-2222-03) | 09 Sep, 2019 | N/A | No |
| 0322-2222-03 | 90 mL in 1 BOTTLE (0322-2222-03) | 09 Sep, 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 antidiarrheal
Product Elements:
Percy medicine bismuth subsalicylate water calcium hydroxide citric acid monohydrate alcohol glycerin acacia orange oil cinnamon oil potassium carbonate rhubarb sucrose bismuth subsalicylate salicylic acid
Indications and Usage:
Uses: relieves diarrhea, reduces number of bowel movements. helps firm stool. relieves nausea, heartburn, fullness due to overindulgence of food and drink.
Warnings:
Warnings children and teenagers that have or are recovering from chicken pox, flu systems, or flue should not use this product. if nausea, vomiting, or fever occur, consult a doctor because these symptoms could be an early sign of reye syndrome, a rare but serious condition. allergy alert: contains salicylates. do not take if you are - allergic to salicylates (including aspirin) - taking other salicylate products. do not use if you have - blood or black stool - an ulcer - bleeding problem. ask a doctor before use if you are taking any drug for anti coagulation (thinning of the blood), diabetes,gout, arthritis. - when using this product a temporary but harmless darkening of the stool and/or tongue may occur. stop use and consult a doctor if - symptoms get worse - ringing in the ears or loss of hearing occurs - diarrhea lasts more that 2 days. if pregnant or breast feeding ask a professional before use . in case of accidental overdose, get medical help or contact a poison control center
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Dosage and Administration:
Directions (shake well before using) adults and children 12 yrs and over : 2 teaspoonfuls every hour as needed , not to exceed 4 doses in 24 hours and not more than 2 days. children under 12: consult a doctor.
Package Label Principal Display Panel:
Package label percy medicine for diarrhea alcohol 5% 90 ml/ 3 fl oz percy medicine for diarrhea alcohol 5% 90 ml/ 3 fl oz