NDC 36800-558 Topco Fiber Therapy Sugar Free

Psyllium Husk

NDC Product Code 36800-558

NDC 36800-558-80

Package Description: 1040 g in 1 CANISTER

NDC Product Information

Topco Fiber Therapy Sugar Free with NDC 36800-558 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topco Fiber Therapy Sugar Free is psyllium husk. The product's dosage form is powder and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.


Topco Fiber Therapy Sugar Free 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.

  • PSYLLIUM HUSK 3.4 g/5.79g

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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Topco Associates Llc
Labeler Code: 36800
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: 04-18-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Topco Fiber Therapy Sugar Free Product Label Images

Topco Fiber Therapy Sugar Free 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

Other

Drug Facts

Active Ingredient: (In Each Teaspoon)

Psyllium husk approximately 3.4 g

Purpose

Bulk-forming Laxative

Uses:

  • ▪for relief of occasional constipation (irregularity)▪generally produces bowel movement in 12-72 hours

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.

Allergy Alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Otc - Ask Doctor

  • Ask a doctor before use if you have▪a sudden change in bowel habits persisting for 2 weeks▪abdominal pain, nausea or vomiting

Otc - Stop Use

  • Stop use and ask a doctor if▪constipation lasts more than 7 days▪rectal bleeding occursThese may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions:

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.Adults & children 12 years & older:1 rounded teaspoon in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily.Children 6-11 yrs :½ adult dose in 8 oz. of liquid, up to 3 times dailyChildren under 6 yrs:Consult a doctorBulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.

New Users:

Start with 1 serving per day; gradually increase to 3 doses per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other Information:

  • ▪each teaspoon contains: potassium 35 mg; sodium 5 mg▪PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon▪contains a therapeutic fiber▪store at room temperature. Keep the container tightly closed to protect from humidity

Inactive Ingredients:

Aspartame, citric acid, FD&C Yellow 6, maltodextrin, natural and artificial orange flavor, silica.

* Please review the disclaimer below.

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