NDC 0135-0199 Citrucel

NDC Product Code 0135-0199

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Citrucel with NDC 0135-0199 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Citrucel is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: -

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.

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)

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
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: 12-31-2020 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: I 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.

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

* Please review the disclaimer below.