NDC 0135-0089 Citrucel


NDC Product Code 0135-0089

NDC CODE: 0135-0089

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

ORANGE (C48331)
ORANGE (C73406)

NDC Code Structure

NDC 0135-0089-69

Package Description: 454 g in 1 BOTTLE

Price per Unit: $0.01710 per GM

NDC 0135-0089-71

Package Description: 850 g in 1 BOTTLE

Price per Unit: $0.01572 per GM

NDC Product Information

Citrucel with NDC 0135-0089 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 powder, for solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1868843 and 1868847.

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

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.

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.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SUCROSE (UNII: C151H8M554)

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: 09-16-2010 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".

* Please review the disclaimer below.

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 Citrucel® Orange

(in each heaping tablespoon)Methylcellulose (a non-allergenic fiber) 2g

Active Ingredient Citrucel® Sugar Free

(in each rounded tablespoon)Methylcellulose (a non-allergenic fiber) 2g


Bulk-forming fiber laxative


  • •relieves occasional constipation (irregularity) •generally produces a bowel movement in 12-72 hours


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 bleedingThese 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.


  • •MIX 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 •use product at the first sign of constipation or irregularity •put one dose in a full glass of cold water •stir briskly and drink promptly •drinking another glass of water is helpfulCITRUCEL® Orange AgeDoseadults & children 12 years of age and overstart with 1 heaping tablespoon. Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day.children 6 - 11 years of agestart with 2.5 level teaspoons. Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day.children under 6 years of ageconsult a physicianCITRUCEL® Sugar Free AgeDoseadults & children 12 years of age and overstart with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.children 6 - 11 years of agestart with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day.children under 6 years of ageconsult a physician

Other Information (Citrucel® Orange)

  • •each heaping tablespoon contains: calcium 80mg and potassium 110mg •each heaping tablespoon contributes 60 calories from sucrose and maltodextrin •store below 77°F (25°C) •protect contents from humidity •keep tightly closed

Other Information (Citrucel® Sugar Free)

  • •each rounded tablespoon contains: calcium 85mg and potassium 125mg •each rounded tablespoon contributes 24 calories from maltodextrin •store below 77°F (25°C) •protect contents from humidity •keep tightly closed •Phenylketonurics: CONTAINS PHENYLALANINE 52mg per adult dose

Inactive Ingredients (Citrucel® Orange)

Citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, sucrose, titanium dioxide, tricalcium phosphate

Inactive Ingredients (Citrucel® Sugar Free)

Aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin

* Please review the disclaimer below.