Citrucel Powder, For Solution
FDA Label NDC 0135-0089

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Citrucel (NDC 0135-0089). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient citrucel® orange, active ingredient citrucel® sugar free, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 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

  • 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 helpful

    • CITRUCEL® Orange

    Age

    Dose

    adults & children 12 years of age and over

    start with 1 heaping tablespoon. Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day.

    children 6 - 11 years of age

    start 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 age

    consult a physician

    CITRUCEL® Sugar Free

    Age

    Dose

    adults & children 12 years of age and over

    start with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.

    children 6 - 11 years of age

    start with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day.

    children under 6 years of age

    consult 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

Questions Or Comments?

call toll-free 1-800-897-6081

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059 

© 2012 The GSK group of companies or its licensor. All rights reserved.

CITRUCEL® Orange

DIRECTIONS FOR USE (NO SCOOP DOSING):

1. Fill glass with at least 8 oz. of cold water.

2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

CITRUCEL® Sugar Free

DIRECTIONS FOR USE (NO SCOOP DOSING):

1. Fill glass with at least 8 oz. of cold water.

2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Principal Display Panel

NDC 0135-0089-71

Great Taste

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

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

    • orange FLAVOR

    NET WT 30 OZ (850 GRAMS)

    Great Tasting

    CITRUCEL® Orange

    Citrucel is unique because it is:

    • Gentle and clinically proven effective to help relieve occasional constipation*
    • The ONLY fiber that won't ferment to cause excess gas like other fiber products**
    • 100% Soluble, gluten-free, non-allergenic fiber
    •  *When Used As Directed.
    •  **Based On Laboratory Testing. Individual Results May Vary. Among Top 5 National Brands.

      • TAMPER EVIDENT PACKAGE

      BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.

      105079XB

      NDC 0135-0090-74

      Great Taste

      CITRUCEL®

      METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

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

        • sugar free ORANGE FLAVOR

        NET WT 32 OZ (907 GRAMS)

        Great Tasting Orange Flavor

        CITRUCEL® Sugar Free

        Citrucel is unique because it is:

        • Gentle and clinically proven effective to help relieve occasional constipation*
        • The ONLY fiber that won't ferment to cause excess gas like other fiber products**
        • 100% Soluble, gluten-free, and non-allergenic
        •  *When Used As Directed.
        •  **Based On Laboratory Testing. Individual Results May Vary. Among Top 5 National Brands.

          • TAMPER EVIDENT PACKAGE

          BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.

          105088XB

* Please review the disclaimer below.