NDC 69842-524 Cvs Health

Natural Fiber Supplement

NDC Product Code 69842-524

NDC 69842-524-75

Package Description: 450 g in 1 BOTTLE, PLASTIC

NDC Product Information

Cvs Health with NDC 69842-524 is a a human over the counter drug product labeled by Cvs Pharmacy,inc.. The generic name of Cvs Health is natural fiber supplement. The product's dosage form is powder and is administered via oral form.

Labeler Name: Cvs Pharmacy,inc.

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.

Cvs Health 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 6 g/6g

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.

  • WATER (UNII: 059QF0KO0R)

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: Cvs Pharmacy,inc.
Labeler Code: 69842
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: 05-15-2019 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.

Cvs Health 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 Dose)

Psyllium Hydrophilic Mucilloid 6 grams

Purpose

Bulk-Forming Laxative

Use

For relief of occasional constipation and to induce regularity. Generally produces bowel movements within 12-72 hours.

Warnings

Allergy alert: As with any natural grain product, inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to psyllium.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.

Do Not Use

Laxative products when abdominal pain, nausea or vomiting is present unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • ▪a sudden change in bowel habits that persists over a period of two weeks

Stop Use And Ask A Doctor If

  • ▪you experience rectal bleeding ▪you fail to have a bowel movement

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

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 fluid may cause choking. See choking warnings.Adults and children 12 years and older: put one dose (one rounded teaspoonful) into a shaker cup or closed container; add a least 8 oz. of juice, water or other beverage ;shake 3 to 5 seconds; drink promptly; if mixture thickens and more fluid, stir; follow with additional fluid to aid product action ;take 1-3 times daily.Children 6 years to under 12 years: 1/2 adult dose, in 8 oz. of fluid; 1-3 times daily.Children under 6 years: ask adoctor.

Other Information

  • ▪each 6.0 gram dose contains: Calcium 10 mg, Potassium 55 mg, Sodium 5 mg▪maximum daily dose (3 teaspoonful) is very low in sodium▪Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines.▪No additives, No sugars, gluten free. No flavors ,100% Natural ▪Safe for diabetics, non-habit-forming▪tamper-evident bottle mouth sealed for your protection  ▪do not use if imprinted inner seal is broken or missing▪store below 86 °F (30°C) ▪keep container tightly closed-protect from excessive moisture ▪can be taken 1 to 3 times daily, before or after meals, mornings or evenings

Inactive Ingredients

Water

* Please review the disclaimer below.