NDC 0135-0090 Citrucel

NDC Product Code 0135-0090

NDC 0135-0090-70

Package Description: 479 g in 1 BOTTLE

NDC 0135-0090-74

Package Description: 907 g in 1 BOTTLE

NDC 0135-0090-75

Package Description: 1191 g 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 0135-0090 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • RIBOFLAVIN (UNII: TLM2976OFR)
  • SUCROSE (UNII: C151H8M554)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • ASPARTAME (UNII: Z0H242BBR1)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MALIC ACID (UNII: 817L1N4CKP)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • RIBOFLAVIN (UNII: TLM2976OFR)

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: 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: 12-31-2020 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 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

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 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.

Directions

  • •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.