Citrucel Tablet
FDA Label NDC 0135-0199

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 0135-0199). 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 (in each caplet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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.

Age

Dose

Maximum Dose

adults & children 12 years of age and over

start with 2 caplets. Increase as needed up to 6 times per day.

do not exceed 12 caplets per day

children 6 - 11 years of age

start with 1 caplet. Increase as needed up to 6 times per day.

do not exceed 6 caplets per day

children under 6 years of age

consult a physician

consult 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

Questions Or Comments?

call toll-free 1-800-897-6081

Additional Information Found On Label

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Patent 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

Principal Display Panel

NDC 0135-0199-02

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

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

    • 100 Fiber caplets

    105118XB

* Please review the disclaimer below.