Drug Facts

Manufacturer: Major Pharmaceuticals
Effective date: 2026-09-24
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: daily-update
Hydrated at: 2026-09-26 01:01:06

Label at a glance#

ProductFIBER THERAPY

Active ingredientMETHYLCELLULOSE (4000 MPA.S)

Label structure9 sections

Indications and uses

• relieves constipation (irregularity) • helps to restore and maintain regularity • for treating bowel disorders when recommended by a doctor • generally provide effect in 12-72 hours

Dosage and administration

• 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 Age Dose adults & children above 12 yea...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 19g adult dose/ rounded tablespoon)

Methylcellulose 2g (a non-allergenic fiber)

Purpose

OTC - PURPOSE SECTION

Bulk-forming fiber laxative

Uses

INDICATIONS & USAGE SECTION

relieves constipation (irregularity)
helps to restore and maintain regularity
for treating bowel disorders when recommended by a doctor
generally provide effect 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/PHARMACIST SECTION

abdominal pain, nausea or vomiting
a sudden change in bowel habits that persists over a period of 2 weeks
sensitivity to any of the ingredients

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding
you fail to have a bowl movement after use.
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 at 1-800-222-1222.

When using this product

SPL UNCLASSIFIED SECTION

do not exceed recommended maximum daily dose unless directed by a doctor
do not use laxative products for a period longer than one week unless directed by a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

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

Age

Dose

adults & children above 12 years of age and over

One rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity

children 6 - 12 years of age

Children under 6 years of age

half the adult dose in 8 ounces of water once daily.

ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Each adult dose contains approximately
3mg of sodium
105mg potassium
contributes 60 calories from sucrose and sorbitol
store at room temperature
protect contents from humidity
keep tightly closed

Tamper Evident: Do not use if printed seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, , silica, sucrose,

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-616-2471

*This product is not manufactured or distributed by GlaxoSmithKline the distributor of CITRUCEL®

Distributed by:

MAJOR^® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152, USA

DIRECTIONS FOR USE

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

Image of stirring water after adding Citrucel

2. Add the adult or child dose listed in the directions. 3. Stir briskly until dissolved and drink promptly. Drinking an additional glass of water is helpful.

Boxed Warning section

TAMPER EVIDENT PACKAGE

Do not use if printed seal under cap is torn or missing.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0904-5675-16

FIBER THERAPY

Methylcellulose

Easy to Mix

No Gritty Texture

100% Soluble Fiber for Controlled Regularity

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5675-16	GM - Gram	0904-5675	7a3396ba-c297-44a4-97bc-615391dd2415	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METHYLCELLULOSE (4000 MPA.S)	ACTIVE INGREDIENT	MRJ667KA5E	1
METHYLCELLULOSE (4000 MPA.S)	ACTIVE MOIETY	MRJ667KA5E	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	1
RIBOFLAVIN	INACTIVE INGREDIENT	TLM2976OFR	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

FIBER THERAPY
methylcellulose
METHYLCELLULOSE (4000 MPA.S)
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
POTASSIUM CITRATE
RIBOFLAVIN
SUCROSE
SILICON DIOXIDE
SORBITOL
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-5675	0904-5675-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHYLCELLULOSE (4000 MPA.S)	MRJ667KA5E	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
POTASSIUM CITRATE	EE90ONI6FF	IACT
RIBOFLAVIN	TLM2976OFR	IACT
SUCROSE	C151H8M554	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITOL	506T60A25R	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
10	2025-09-19	full-release	2026-06-01 01:14:16

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 2 · 106 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 58 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 58 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	POWDER, FOR SOLUTION / ORAL		570 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SOLUTION / ORAL		40 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii+route 58 equally ranked IID candidates
RIBOFLAVIN	RIBOFLAVIN	TLM2976OFR	TABLET / ORAL	0.03 mg		Exact identifier — unii+route 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii+route 58 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SOLUTION / ORAL		40 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii+route 58 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii+route 58 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
RIBOFLAVIN	RIBOFLAVIN	TLM2976OFR	TABLET / ORAL	0.03 mg		Exact identifier — unii+route 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii+route 58 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3f25c445-bbb0-2500-e063-6294a90aea41			5dddab8d-0041-4486-9ed9-1dbd13575b47	2025-09-19	Boxed warning, Warnings	Exact identifier spl set id: 5dddab8d-0041-4486-9ed9-1dbd13575b47

Reported adverse events (FAERS/openFDA)#

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