Fiber laxative

Manufacturer: McKesson
Effective date: 2014-04-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:38:58

Label at a glance#

ProductFiber laxative

Active ingredientPSYLLIUM HUSK

Label structure9 sections

Indications and uses

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

Dosage and administration

take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning. swallow capsules one at a time daily maximum 3 doses dosage will vary according to diet, exercise, previous laxative use or severity of constipation. product generally produces effect in 12-72 hours. adults and children 12 years and older 5 caps...

Storage and handling

do not use if printed seal under cap is torn or missing. store at room temperature protect contents from moisture.

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Psyllium husk approx. 0.52 g

Purpose

OTC - PURPOSE SECTION

Fiber laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Uses

INDICATIONS & USAGE SECTION

relieves:

occasional constipation
helps restore regularity
promotes normal function of the bowel

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

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

When using this product

OTC - WHEN USING SECTION

it may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

Stop use and ask a doctor if

OTC - STOP USE SECTION

you fail to have a bowel movement after use
rectal bleeding occurs
symptoms persist more than 1 week
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
swallow capsules one at a time
daily maximum 3 doses
dosage will vary according to diet, exercise, previous laxative use or severity of constipation.
product generally produces effect in 12-72 hours.

adults and children 12 years and older	5 capsules, 1 to 3 times a day
children 6 to under 11 years	consider use of powder form of product
children under 6 years	ask a doctor

Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

Other information

STORAGE AND HANDLING SECTION

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

caramel color, gelatin, iron oxide, polysorbate 80, shellac

Fiber Supplement information

SPL UNCLASSIFIED SECTION

Uses: An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One serving of this product provides 2.4 grams of this soluble fiber. consult a doctor if you are considering use of this product as part of a cholesterol lowering program.

Warnings: Read entire label, including warnings in Drug Facts

Directions: Adults 12 years and older: 2-6 capsules for increasing daily fiber intake; 6 capsules for cholesterol lowering use. Take this product 8oz. of liquid (swallow 1 capsule at a time) up to 3 times daily. NOTICE: Take this product atleast 8 oz . (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing.

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunmark

compare to Metamucil^® capsules active ingredient

fiber laxative

Relieves constipation, restores regularity

dietary fiber supplement

160 capsulesPDP

PEELBACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581417	psyllium 0.52 GM Oral Capsule	PSN	1
581417	psyllium 520 MG Oral Capsule	SCD	1
581417	psyllium 0.52 GM Oral Capsule	SY	1

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0010939789334	GTIN-13: 0010939789334 EAN-13: 0010939789334 GTIN-12: 010939789334 UPC-A: 010939789334 GTIN storage (14 digits): 00010939789334	SM650F.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49348-633-49	2020-01-31	C162847	48780-1	9d75b9d0-ff5b-f424-e053-dadaa90a57ce	Sunmark Fiber Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-633-49	Fiber laxative	160 in 1 BOTTLE	CAPSULE	160		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-633	FIBER LAXATIVE (PSYLLIUM HUSK) CAPSULE [MCKESSON]	1	Legacy NDC, 1 package rows	20140410_76177615-d98f-482a-afe6-fdc8ea53f55f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-633-49	EA - Each	49348-633	e3c6e427-b339-4bbc-a76d-6b47b6ee8d80	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSYLLIUM HUSK	ACTIVE INGREDIENT	0SHO53407G	1
PSYLLIUM HUSK	ACTIVE MOIETY	0SHO53407G	1
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Fiber laxative
Psyllium husk
CARAMEL
GELATIN
BROWN IRON OXIDE
POLYSORBATE 80
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-633	49348-633-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PSYLLIUM HUSK	0SHO53407G	ACTIB
CARAMEL	T9D99G2B1R	IACT
GELATIN	2G86QN327L	IACT
BROWN IRON OXIDE	1N032N7MFO	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SHELLAC	46N107B71O	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 3 · 147 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	53 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
BROWN IRON OXIDE	BROWN IRON OXIDE	1N032N7MFO	CAPSULE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYSTEM / TOPICAL		1050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	SYRUP / ORAL	207 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / NASAL	50 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
BROWN IRON OXIDE	BROWN IRON OXIDE	1N032N7MFO	TABLET / ORAL	0.79 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	GRANULE, FOR SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / SUBCUTANEOUS	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / VAGINAL	28 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LOTION / TOPICAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 78 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
ce441faa-49d4-45fb-a13d-ea6396db77c8			76177615-d98f-482a-afe6-fdc8ea53f55f	2014-04-10	Warnings	Exact identifier spl id: ce441faa-49d4-45fb-a13d-ea6396db77c8 spl set id: 76177615-d98f-482a-afe6-fdc8ea53f55f

Reported adverse events (FAERS/openFDA)#

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