NDC 0135-0199 Citrucel

Methylcellulose

  1. Labeler Index
  2. Glaxosmithkline Consumer Healthcare Holdings (us) Llc
  3. NDC: 0135-0199 Citrucel

NDC Product Code 0135-0199

NDC CODE: 0135-0199

Proprietary Name: Citrucel 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • 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):
ORANGE (C48331)
Shape: FREEFORM (C48340)
Size(s):
19 MM
Imprint(s):
CIT
Score: 1

NDC Code Structure

NDC 0135-0199-01

Package Description: 180 TABLET in 1 BOTTLE

NDC 0135-0199-02

Package Description: 100 TABLET in 1 BOTTLE

NDC 0135-0199-06

Package Description: 2 TABLET in 1 POUCH

NDC 0135-0199-07

Package Description: 240 TABLET in 1 BOTTLE

NDC 0135-0199-08

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

NDC 0135-0199-09

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

NDC Product Information

Citrucel with NDC 0135-0199 is a 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.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

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.

Citrucel 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.
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • 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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
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: 02-01-2010 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: 12-31-2022 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".

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Citrucel Product Label Images

Citrucel 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 (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.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 agestart with 1 caplet. Increase as needed up to 6 times per day.do not exceed 6 caplets per daychildren under 6 years of ageconsult a physicianconsult 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

Additional Information Found On Label

TAMPER EVIDENT PACKAGEBOTTLE SEALED WITH PRINTED FOIL UNDER CAP.DO NOT USE IF FOIL IS MISSING OR BROKEN.Distributed by:GSK Consumer HealthcareWarren, NJ 07059Patent 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

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