Equalactin Laxative
Calcium Polycarbophil
Numark Brands, Inc
Human Otc Drug
NDC 69846-000Equalactin Laxative also known as Calcium Polycarbophil is a human otc drug labeled by 'Numark Brands, Inc'. National Drug Code (NDC) number for Equalactin Laxative is 69846-000. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Equalactin Laxative drug includes Calcium Polycarbophil - 625 mg/1 . The currest status of Equalactin Laxative drug is Active.
Drug Information:
| Drug NDC: | 69846-000 |
| 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: | Equalactin Laxative |
| 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: | Calcium Polycarbophil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Numark Brands, Inc |
| 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: | CALCIUM POLYCARBOPHIL - 625 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: | 21 Nov, 1986 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jun, 2026 |
| 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: | part334 |
| 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: | NUMARK BRANDS, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 210659
308933
|
| 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: | 8F049NKY49
|
| 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 |
|---|
| 69846-000-26 | 2 BLISTER PACK in 1 CARTON (69846-000-26) / 12 TABLET in 1 BLISTER PACK | 21 Nov, 1986 | 03 Mar, 2023 | No |
| 69846-000-27 | 4 BLISTER PACK in 1 CARTON (69846-000-27) / 12 TABLET in 1 BLISTER PACK | 21 Nov, 1986 | 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:
Active ingredients purpose calcium polycarbophil 625 mg (equivalent to 500 mg polycarbophil) bulk for mixing laxative
Product Elements:
Equalactin laxative calcium polycarbophil calcium polycarbophil polycarbophil citric acid monohydrate crospovidone dextrose, unspecified form magnesium stearate maltodextrin cellulose, microcrystalline sucralose e carton
Indications and Usage:
Use for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 - 72 hours.
Warnings:
Warnings do not use this product for more than 1 week unless directed by a doctor
Dosage and Administration:
Directions drink a full glass (8 fl. oz.) of liquid with each dose chew tablets thoroughly do not swallow tablets whole adults and children 12 years of age and over up to 8 tablets daily in divided doses of 2 tablets per dose children 6 to under 12 years of age up to 4 tablets daily in divided doses of 1 tablet per dose children 2 to under 6 years of age up to 2 tablets daily in divided doses of 1 tablet per dose children under 2 years of age consult a doctor
Stop Use:
Stop use and ask a doctor if rectal bleeding occurs you fail to have bowel movement after use of laxative. these may indicate a serious condition
Package Label Principal Display Panel:
Principal display panel equalactin ® bulk forming laxative relieves symptoms of nervous stomach irregularity abdominal discomfort loose bowels constipation 48 citrus flavored chewable tablets nervous stomach (similar to irritable bowel), with its symptoms of loose bowels, irregularity, abdominal discomfort and constipation, is caused by water imbalance in the bowel, and afflicts millions. equalactin provides relief by equalizing the water balance to restore normal bowel movements. when you feel the onset of nervous stomach symptoms, take equalactin to provide relief and prevent the episode from becoming severe. distributed by: numark brands, inc. edison, nj 08818 rev. 12/18 10001c
Further Questions:
Questions? 1-800-331-0221