NDC 63868-166 Cdma Fiber Therapy

Methylcellulose

NDC Product Code 63868-166

NDC Code: 63868-166

Proprietary Name: Cdma Fiber Therapy 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
Color(s):
ORANGE (C48331 - LIGHT ORANGE)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
RP122
Score: 1

Code Structure
  • 63868 - Chain Drug Marketing Association
    • 63868-166 - Cdma Fiber Therapy

NDC 63868-166-10

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Cdma Fiber Therapy with NDC 63868-166 is a a human over the counter drug product labeled by Chain Drug Marketing Association. The generic name of Cdma Fiber Therapy is methylcellulose. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Chain Drug Marketing Association

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.


Cdma Fiber Therapy 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.

  • METHYLCELLULOSE (4000 MPA.S) 500 mg/1

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.

  • ADIPIC ACID (UNII: 76A0JE0FKJ)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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: Chain Drug Marketing Association
Labeler Code: 63868
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: 04-19-2019 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.

Cdma Fiber Therapy Product Label Images

Cdma Fiber Therapy 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 500mg

Purpose

Bulk-forming fiber laxative (a non-allergenic fiber)

Uses

  • •helps restore and maintain regularity •relieves constipation (irregularity) •for constipation associated with other bowel disorders like IBS when recommended by a doctor. •generally produces a bowel movement in 12 -72 hours.

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

  • •a sudden change in bowel habits that persists over a period of two weeks •abdominal pain, nausea or vomiting

Stop Use And Ask A Doctor If

  • •Constipation lasts more than 7 days •you have rectal bleeding •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 at 1-800-222-1222.

Directions

Take 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.AgeDoseMaximum Doseadults & children 12 years of age and overstart with 2 caplets. Increase as needed up to 6 times per day. Do not exceed 12 caplets per dayChildren 6-11 years of age Start with 1 caplet. Increase as needed up to 6 times per dayDo not exceed 6 caplets per daychildren under 6 years of ageConsult a physicianConsult a physician

Other Information

  • •each caplet contains: appx. 18 mg of calcium •store at below 77° F (25°C) •protect contents from humidity •keep tightly closedSafety sealed: Do not use if printed seal under cap is torn or missing.

Inactive Ingredients

Adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polysorbate 80, silica. Do not use if printed seal under cap is torn or missing.

* Please review the disclaimer below.

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