NDC 63868-530 Quality Choice

Calcium Polycarbophil

NDC Product Code 63868-530

NDC Code: 63868-530

Proprietary Name: Quality Choice 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: Calcium Polycarbophil 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):
BROWN (C48332)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
RP120
Score: 1

NDC Code Structure

  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-530 - Quality Choice

NDC 63868-530-90

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Quality Choice with NDC 63868-530 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Quality Choice is calcium polycarbophil. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Quality Choice 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.

  • CALCIUM POLYCARBOPHIL 625 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARAMEL (UNII: T9D99G2B1R)
  • CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: Quality Choice (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: 04-16-2019 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.

Quality Choice Product Label Images

Quality Choice 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

Drug Fats

Active Ingredient (in each caplet)Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Otc - Purpose

PURPOSEBulk-forming fiber laxative

Uses

  • •relieves occasional constipation to help restore and maintain regularity •this product generally produces bowel movement in 12 to 72 hours

Warnings

Choking Warning: 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

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When Using This Product

  • •do not use for more than 7 days unless directed by a doctor •do not take more than 8 tablets in a 24 hour period unless directed by a doctor

Stop Use And Ask A Doctor If

Rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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

Directions

  • •Take each dose of this product 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). •This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.AgeRecommendedDaily maximumadults & children 12 years of age and over2 caplets once a dayup to 4 times a daychildren under 12 yearsconsult a physician

Other Information

  • •each caplet contains: calcium 125 mg •do not use if imprinted safety seal under cap is broken or missing •store at 20-25°C (68-77°F) •protect contents from moisture

Inactive Ingredient

Calcium carbonate, caramel, crospovidone, hypromellose, microcrystalline cellulose, maltodextrin, magnesium stearate, polyethylene glycol, silica, sodium lauryl sulfate.

* Please review the disclaimer below.

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