Leader Fiber

Manufacturer: State of Florida DOH Central Pharmacy
Effective date: 2014-03-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:28

Label at a glance#

ProductLeader Fiber

Active ingredientCALCIUM POLYCARBOPHIL

Label structure8 sections

Indications and uses

relieves: constipation helps restore & maintain regularity promotes normal function of the bowel

Dosage and administration

take this product (child or adult dose) with a full glass of water (8oz) daily maximum 4 doses dosage may vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician

Storage and handling

each caplet contains: calcium 122 mg do not use if printed seal under cap is torn or missing store at room temperature protect contents from moisture

Contacts and useful links#

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Calcium polycarbophil 625 mg

Purpose

OTC - PURPOSE SECTION

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

relieves:

constipation
helps restore & maintain regularity
promotes normal function of the bowel

Warnings

WARNINGS SECTION

Do not use if

you have abdominal pain, nausea or vomiting
you have difficulty in swallowing
you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
you fail to have a bowel movement after use
rectal bleeding occurs
symptoms persist more than 1 week

Drug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic

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 a full glass of water (8oz)
daily maximum 4 doses
dosage may vary according to diet, exercise, previous laxative use or severity of constipation
continued use for 1 to 3 days is normally required to provide full benefit
adults and children 12 years of age and over 2 caplets once a day up to 4 times a day
children under 12 years consult a physician

Other information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 122 mg
do not use if printed seal under cap is torn or missing
store at room temperature
protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, caramel, crospovidone, hypromellose, maltodextrin, microcrystalline cellulose, magnesium stearate, methylcellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed By:

Cardinal Health

Dublin Ohio 43017

www.myleader.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

Label Image for 53808-0963
625mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308934	calcium polycarbophil 625 MG Oral Tablet	PSN	1
308934	calcium polycarbophil 625 MG Oral Tablet	SCD	1
308934	calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0963-1	2020-01-31	C162847	48780-1	9d75b9d1-14c4-f424-e053-dadaa90a57ce	Leader Fiber Caplets Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0963-1	Leader Fiber	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0963	LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20141007_e7d790fb-5dfc-4628-a70b-f617581e1ee6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-213-75	EA - Each	37205-213	5be69b3d-1765-4611-93d9-850d98c62e66	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALCIUM POLYCARBOPHIL	ACTIVE INGREDIENT	8F049NKY49	1
POLYCARBOPHIL	ACTIVE MOIETY	W25LM17A4W	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
POLYETHYLENE GLYCOL 200	INACTIVE INGREDIENT	R95B8J264J	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Leader Fiber
Calcium polycarbophil
POLYCARBOPHIL
CALCIUM CARBONATE
CARAMEL
CROSPOVIDONE
HYPROMELLOSE 2208 (100 MPA.S)
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 200
COLLOIDAL SILICON DIOXIDE
SODIUM LAURYL SULFATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53808-0963	53808-0963-1
37205-213

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM POLYCARBOPHIL	8F049NKY49	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
CARAMEL	T9D99G2B1R	IACT
CROSPOVIDONE	68401960MK	IACT
HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 200	R95B8J264J	IACT
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT

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 4 · 214 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	TABLET / BUCCAL		21 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LOTION / TOPICAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	SUSPENSION / ORAL	111.12 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LIQUID / ORAL	5.3 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, CHEWABLE / ORAL		1650 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	CAPSULE, EXTENDED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	SUSPENSION / ORAL		50 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 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
ce8f069a-db9a-4f98-856f-cccc4fb48d45			e7d790fb-5dfc-4628-a70b-f617581e1ee6	2014-03-03	Warnings	Exact identifier spl id: ce8f069a-db9a-4f98-856f-cccc4fb48d45 spl set id: e7d790fb-5dfc-4628-a70b-f617581e1ee6

Reported adverse events (FAERS/openFDA)#

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

adults and children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician