NDC 0135-0199 Citrucel
Methylcellulose Tablet Oral

Product Information

What is NDC 0135-0199?

The NDC code 0135-0199 is assigned by the FDA to the product Citrucel which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Citrucel is methylcellulose. The product's dosage form is tablet and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 0135-0199-01 180 tablet in 1 bottle , 0135-0199-02 100 tablet in 1 bottle , 0135-0199-06 2 tablet in 1 pouch , 0135-0199-07 240 tablet in 1 bottle , 0135-0199-08 50 pouch in 1 carton / 2 tablet in 1 pouch (0135-0199-06), 0135-0199-09 1 bottle in 1 package / 240 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.

NDC Product Code0135-0199
Proprietary Name 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.
Citrucel
Non-Proprietary Name 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.
Methylcellulose
Product Type 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.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number 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.
part334
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-01-2010
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Citrucel?


Product Characteristics

Color(s)ORANGE (C48331)
ShapeFREEFORM (C48340)
Size(s)19 MM
Imprint(s)CIT
Score1

Product Packages

NDC Code 0135-0199-01

Package Description: 180 TABLET in 1 BOTTLE

Price per Unit: $0.13202 per EA

NDC Code 0135-0199-02

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.13202 per EA

NDC Code 0135-0199-06

Package Description: 2 TABLET in 1 POUCH

NDC Code 0135-0199-07

Package Description: 240 TABLET in 1 BOTTLE

Price per Unit: $0.13202 per EA

NDC Code 0135-0199-08

Package Description: 50 POUCH in 1 CARTON / 2 TABLET in 1 POUCH (0135-0199-06)

NDC Code 0135-0199-09

Package Description: 1 BOTTLE in 1 PACKAGE / 240 TABLET in 1 BOTTLE

Product Details

What are Citrucel Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Citrucel Active Ingredients UNII Codes

  • METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)
  • METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Citrucel Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Citrucel 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)



Methylcellulose (a non-allergenic fiber) 500mg


Purpose



Bulk-forming fiber laxative


Uses



  • •relieves occasional constipation (irregularity)
  • •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 for 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.


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.

Age

Dose

Maximum Dose

adults & children 12 years of age and over

start with 2 caplets. Increase as needed up to 6 times per day.

do not exceed 12 caplets per day

children 6 - 11 years of age

start with 1 caplet. Increase as needed up to 6 times per day.

do not exceed 6 caplets per day

children under 6 years of age

consult a physician

consult a physician


Other Information



  • each caplet contains: calcium 10mg
  • •store below 77oF (25oC)
  • •protect contents from humidity
  • •keep tightly closed

Inactive Ingredients



crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate


Questions Or Comments?



call toll-free 1-800-897-6081


Additional Information Found On Label



TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Patent Nos. 6350469, 7125562, 6372253, 7132114.

©2012 GSK or its licensor.

*When Used As Directed.

**Based On Laboratory Testing.

Individual Results May Vary.

Among Top 5 National Brands.

Trademarks are owned by or licensed to the GSK group of companies


Principal Display Panel



NDC 0135-0199-02

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

  • •Gentle and clinically proven effective*
  • •Gives you additional fiber to help relieve occasional constipation
  • •The ONLY fiber for regularity that won’t cause excess gas**
  • 100 Fiber caplets

    105118XB


* Please review the disclaimer below.