CITRUCEL

Manufacturer
Haleon US Holdings LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 00:40:40

Label at a glance#

ProductCITRUCEL
Active ingredientMETHYLCELLULOSE (4000 MPA.S)
Label structure10 sections

Indications and uses

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

Dosage and administration

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 u...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Methylcellulose (a non-allergenic fiber) 500mg

Purpose

OTC - PURPOSE SECTION

Bulk-forming fiber laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • a sudden change in bowel habits that persists for two weeks
  • abdominal pain, nausea or vomiting

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • constipation lasts more than 7 days
  • you have rectal bleeding

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 10mg
  • store below 77 oF (25 oC)
  • protect contents from humidity
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-897-6081

Additional information found on label

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

*When Used As Directed.

**Based On Laboratory Testing.

Individual Results May Vary.

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

©2018 GSK or its licensor.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0199-01

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

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

180 Fiber caplets

105120XC

105120XC_Citrucel Caplets_180 caps.JPG
105120XC_Citrucel Caplets_180 caps.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
352178Citrucel 500 MG Oral TabletPSN22
198750methylcellulose 500 MG Oral TabletPSN22
352178methylcellulose 500 MG Oral Tablet [Citrucel]SBD22
198750methylcellulose 500 MG Oral TabletSCD22
352178Citrucel 500 MG Oral TabletSY22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0199-012020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-022020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-062020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-072020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-082020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-092020-11-17C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-012020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-022020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-062020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-072020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-082020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-092020-09-27C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-012020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-022020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-062020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-072020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-082020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-092020-09-25C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-012020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-022020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-062020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-072020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-082020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts
0135-0199-092020-07-22C16284748780-1ab0e2407-3443-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0199-01CITRUCEL180 in 1 BOTTLETABLET18022
0135-0199-02CITRUCEL100 in 1 BOTTLETABLET10022
0135-0199-06CITRUCEL2 in 1 POUCHTABLET222
0135-0199-07CITRUCEL240 in 1 BOTTLETABLET24022
0135-0199-08CITRUCEL50 in 1 CARTONTABLET5022
0135-0199-09CITRUCEL240 in 1 BOTTLETABLET24022
0135-0199-09CITRUCEL1 in 1 PACKAGETABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0199CITRUCEL (METHYLCELLULOSE) TABLET [HALEON US HOLDINGS LLC]22Current NDC, Legacy NDC, 7 package rows20241207_d27f6742-2dcc-451e-b803-6ffe183038ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0199-01EA - Each0135-01990fc0dff5-c2c6-489e-996a-a1658d61b1d712016-06-14
0135-0199-02EA - Each0135-0199bec110d8-0d3d-4957-8eb9-8b1c8713acc212012-07-24
0135-0199-07EA - Each0135-019966fb4ea1-6d94-427e-b0f5-da046444379c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METHYLCELLULOSE (4000 MPA.S)ACTIVE INGREDIENTMRJ667KA5E9
METHYLCELLULOSE (4000 MPA.S)ACTIVE MOIETYMRJ667KA5E9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69339
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J9
CROSPOVIDONEINACTIVE INGREDIENT68401960MK9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A89
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I309
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D9
POVIDONESINACTIVE INGREDIENTFZ989GH94E9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-01990135-0199-01, 0135-0199-02, 0135-0199-06, 0135-0199-07, 0135-0199-08, 0135-0199-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 49 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
ndc (package): 0135-0199-06
ndc (package): 0135-0199-09
ndc (package): 0135-0199-08
ndc (package): 0135-0199-02
ndc (package): 0135-0199-07
ndc (package): 0135-0199-01
ndc (product): 0135-0199
ndc11 (package): 00135019901
ndc11 (package): 00135019902
ndc11 (package): 00135019908
ndc11 (package): 00135019909
ndc11 (package): 00135019906
ndc11 (package): 00135019907
spl id: 6df5275a-78c1-452c-a061-4202a131969f
spl set id: d27f6742-2dcc-451e-b803-6ffe183038ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.