Sunmark Fiber Laxative
Methylcellulose
Strategic Sourcing Services Llc
Human Otc Drug
NDC 49348-541Sunmark Fiber Laxative also known as Methylcellulose is a human otc drug labeled by 'Strategic Sourcing Services Llc'. National Drug Code (NDC) number for Sunmark Fiber Laxative is 49348-541. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sunmark Fiber Laxative drug includes Methylcellulose (4000 Cps) - 500 mg/1 . The currest status of Sunmark Fiber Laxative drug is Active.
Drug Information:
| Drug NDC: | 49348-541 |
| 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: | Sunmark Fiber 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: | Methylcellulose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Strategic Sourcing Services Llc |
| 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: | METHYLCELLULOSE (4000 CPS) - 500 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: | 26 Sep, 2019 |
| 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: | 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: | Strategic Sourcing Services LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198750
|
| 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: | MRJ667KA5E
|
| 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 |
|---|
| 49348-541-10 | 100 TABLET in 1 BOTTLE (49348-541-10) | 26 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 bulk-forming laxative
Product Elements:
Sunmark fiber laxative methylcellulose methylcellulose (4000 cps) methylcellulose (4000 cps) anhydrous citric acid silicon dioxide crospovidone fd&c yellow no. 6 magnesium stearate microcrystalline cellulose sodium bicarbonate sodium chloride sodium lauryl sulfate caplet g188
Indications and Usage:
Uses relieves occasional constipation to help restore and maintain regularity generally produces a bowel movement in 12-72 hours
Warnings:
Warnings choking: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. do not take this product if you have difficulty in swallowing. if you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits that persists over a period of 2 weeks when using this product do not use laxative products for a period longer than one week unless directed by a doctor do not use if you are on a low salt diet unless directed by a doctor stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement after use these could be signs of a serious condition keep out of reach of children in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not use laxative products for a period longer than one week unless directed by a doctor do not use if you are on a low salt diet unless directed by a doctor
Dosage and Administration:
Directions this product generally produces effect in 12-72 hours take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid taking this product without enough liquid may cause choking, see choking warning age dose maximum dose adults and children 12 years & over 2 caplets up to 6 times daily children 6 to 11 years 1 caplet up to 6 times daily children under 6 years ask a doctor ask a doctor
Stop Use:
Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement after use these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel sunmark compare to citrucel ® caplets active ingredient* fiber laxative bulk-forming laxative daily source of 100% soluble fiber methylcellulose 500 mg the fiber with no excess gas 100 caplets image description