NDC 36800-465 Fiber Laxative
Calcium Polycarbophil Tablet Oral
Product Information
What is NDC 36800-465?
The NDC code 36800-465 is assigned by the FDA to the product Fiber Laxative which is a human over the counter drug product labeled by Topco Associates, Llc. The generic name of Fiber Laxative is calcium polycarbophil. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 36800-465-27 90 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Fiber Laxative?
This medication is used to treat constipation. It increases the bulk in your stool, an effect that helps to cause movement of the intestines. It also works by increasing the amount of water in the stool, making the stool softer and easier to pass. Psyllium, one type of bulk-forming laxative, has also been used along with a proper diet to treat high cholesterol.
Product Characteristics
Color(s) | WHITE (C48325 - OFF WHITE) |
Shape | CAPSULE (C48336) |
Size(s) | 18 MM |
Imprint(s) | G147 |
Score | 1 |
Product Details
What are Fiber Laxative Active Ingredients?
Fiber Laxative Active Ingredients UNII Codes
- CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)
- POLYCARBOPHIL (UNII: W25LM17A4W) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 308934 - calcium polycarbophil 625 MG Oral Tablet
- RxCUI: 308934 - calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet
Fiber Laxative Inactive Ingredients UNII Codes
- CALCIUM CARBONATE (UNII: H0G9379FGK)
- CARAMEL (UNII: T9D99G2B1R)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
* Please review the disclaimer below.
Fiber Laxative Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Active Ingredient (In Each Caplet)
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
Purpose
Bulk-forming laxative
Use(S)
- relieves occasional constipation
- this product generally produces bowel movement in 12 to 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
- abdominal pain, nausea or vomiting
- difficulty in swallowing
- 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 caplets in a 24 hour period unless directed by a doctor
Stop Use And Ask Doctor If
- you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
- you fail to have a bowel movement after use or have rectal bleeding.
These could be signs of a serious condition.
Keep Out Of Reach Of Children
In case of over dose, get medical help or contact a Poison Control Center immediately.
Directions
- take this product (child or adult dose) with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning.
- dosage will vary according to diet, exercise, previous laxative use or severity of constipation
- continued use for 1 to 3 days is normally required to provide full benefit
adults and children 12 years and over | 2 caplets, 1 to 4 times a day |
children under 12 years | ask a doctor |
Other Information
- each caplet contains: calcium 135 mg
- store at room temperature
- protect contents from moisture
Inactive Ingredients
calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.
Principal Display Panel
NDC 36800-465-27
Topcare`
COMPARE TO FIBERCON ACTIVE INGREDIENT
Fiber Laxative
CALCIUM POLYCARBOPHIL 625 mg
BULK-FORMING LAXATIVE
- Gentle Enough for Everyday Use
- Just as Effective as Fiber Powders
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
90 CAPLETS
* Please review the disclaimer below.