Harmon Face Values Anti Diarrheal
Loperamide Hcl
Harmon Stores Inc.
Human Otc Drug
NDC 63940-224Harmon Face Values Anti Diarrheal also known as Loperamide Hcl is a human otc drug labeled by 'Harmon Stores Inc.'. National Drug Code (NDC) number for Harmon Face Values Anti Diarrheal is 63940-224. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Harmon Face Values Anti Diarrheal drug includes Loperamide Hydrochloride - 2 mg/1 . The currest status of Harmon Face Values Anti Diarrheal drug is Active.
Drug Information:
| Drug NDC: | 63940-224 |
| 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: | Harmon Face Values Anti Diarrheal |
| 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: | Loperamide Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harmon Stores Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film 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: | LOPERAMIDE HYDROCHLORIDE - 2 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: | 18 Dec, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | ANDA075232 |
| 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: | Harmon Stores Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 978010
|
| 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: | 0370030510122
|
| UPC stands for Universal Product Code. |
| UNII: | 77TI35393C
|
| 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: | Opioid Agonist [EPC]
Opioid Agonists [MoA]
|
| 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 |
|---|
| 63940-224-53 | 12 BLISTER PACK in 1 CARTON (63940-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 18 Dec, 2011 | 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 anti-diarrheal
Product Elements:
Harmon face values anti diarrheal loperamide hcl loperamide hydrochloride loperamide anhydrous lactose carnauba wax hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified l2
Indications and Usage:
Use controls symptoms of diarrhea, including travelers diarrhea
Warnings:
Warnings allergy alert: do not use if you have ever had a rash or other allergic reaction to loperamide hcl do not use if you have bloody or black stool ask a doctor before use if you have fever mucus in the stool a history of liver disease ask a doctor or pharmacist before use if you are taking antibiotics when using this product tiredness, drowsiness or dizziness may occur. be careful when driving or operating machinery. stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. these may be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222)
Do Not Use:
Warnings allergy alert: do not use if you have ever had a rash or other allergic reaction to loperamide hcl do not use if you have bloody or black stool ask a doctor before use if you have fever mucus in the stool a history of liver disease ask a doctor or pharmacist before use if you are taking antibiotics when using this product tiredness, drowsiness or dizziness may occur. be careful when driving or operating machinery. stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. these may be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222)
When Using:
When using this product tiredness, drowsiness or dizziness may occur. be careful when driving or operating machinery.
Dosage and Administration:
Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. if possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor
Stop Use:
Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare ours to the active ingredient in imodium ® a-d loperamide hydrochloride tablets, 2mg anti-diarrheal controls the symptoms of diarrhea actual size easy to swallow 12 caplets* *each caplet (capsule-shaped tablet) contains 2 mg loperamide hydrochloride anti-diarrheal carton image 1 anti-diarrheal carton image 2
Further Questions:
Questions or comments? 1-800-719-9260