NDC 49348-541 Sunmark Fiber Laxative


NDC Product Code 49348-541

NDC CODE: 49348-541

Proprietary Name: Sunmark Fiber Laxative What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methylcellulose What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

ORANGE (C48331)
Shape: CAPSULE (C48336)
19 MM
Score: 1

NDC Code Structure

  • 49348 - Strategic Sourcing Services Llc

NDC 49348-541-10

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.05846 per EA

NDC Product Information

Sunmark Fiber Laxative with NDC 49348-541 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark Fiber Laxative is methylcellulose. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 198750.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sunmark Fiber Laxative Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Strategic Sourcing Services Llc
Labeler Code: 49348
FDA Application Number: part334 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sunmark Fiber Laxative Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Caplet)

Methylcellulose 500 mg


Bulk-forming laxative


  • Helps restore and maintain regularity and relieves constipation (irregularity)in the treatment of constipation associated with other bowel disorders when recommended by a doctor


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 vomitinga sudden change in bowel habits that persists over a period of 2 weekssensitivity to any of the ingredients

When Using This Product

  • Do not exceed recommended maximum dose unless directed by a doctordo not use laxative products for a period longer than one week unless directed by a doctor

Stop Use And Ask A Doctor If

  • Rectal bleeding occursyou fail to have a bowel movement after use

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away.


  • This product generally produces effect in 12-72 hourstake this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluidtaking this product without enough liquid may cause choking, see choking warningAgeDose                        Maximum Dose      adults and children over 12 years2 capletsup to 6 times dailychildren (6 to 12 years)1 capletup to 6 times dailychildren under 6 yearsask a doctorask a doctor

Other Information

  • Each caplet contains: sodium 10 mgstore at room temperature 15o-30oC (59o-86oF)protect contents from moisturekeep tightly closedtamper evident: Do not use if printed seal under cap is torn or missing

Inactive Ingredients

Citric acid, colloidal silicon dioxide, crospovidone, FD and C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

* Please review the disclaimer below.