Leader Enema

Manufacturer: CARDINAL HEALTH, INC.
Effective date: 2015-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:31:41

Label at a glance#

ProductLeader Enema

Active ingredientSODIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, MONOBASIC

Label structure10 sections

Indications and uses

• relieves occasional constipation

Dosage and administration

Do not use more unless directed by a doctor. See Warnings. adults & children 12 years and over one bottle once daily children 2 to under 12 years ½ bottle once daily children under 2 years do not use Caution: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE. Positioning: Left-side position: Lie ...

Storage and handling

• each 118 mL contains: sodium 4.3 g • store at room temperature 20º-25ºC (68º-77ºF) • this product generally produces bowel movement in 1 to 5 minutes

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-367-4477

Label contents#

Full prescribing information#

Active ingredients (in each 118 mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation

Warnings

WARNINGS SECTION

For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a sodium-restricted diet
abdominal pain, nausea or vomiting
kidney disease, heart problems, or are dehydrated
noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

do not use more than directed. Serious side effects may occur from excess dosage.
do not use for more than 3 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding
you have no bowel movement after use of a laxative

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more unless directed by a doctor. See Warnings.

adults & children 12 years and over	one bottle once daily
children 2 to under 12 years	½ bottle once daily
children under 2 years	do not use

Caution:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Knee-chest position:

Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Administering enema:

With steady pressure, gently insert enema with tip pointing toward navel
squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
Remove tip from rectum.
stop using if tip is hard to insert. Forcing the tip into rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other information

STORAGE AND HANDLING SECTION

each 118 mL contains: sodium 4.3 g
store at room temperature 20º-25ºC (68º-77ºF)
this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-367-4477

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader

Compare to Fleet® Enema Saline active ingredients

READY-TO-USE

Enema

Saline Laxative

For Relief Of Occasional Constipation

Soft, Flexible Comfort Tip

Latex Free

4.5 FL OZ (133ml)

Package Label - Back and Side Label with Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Saline Enema Drug Facts and Side Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-754-11	2025-04-28	C162847	48780-1	9d75b9d0-f71b-f424-e053-dadaa90a57ce	687078d4-53d8-4e45-ab3e-375b5358d719
37205-754-36	2025-04-28	C162847	48780-1	9d75b9d0-f71b-f424-e053-dadaa90a57ce	687078d4-53d8-4e45-ab3e-375b5358d719
37205-754-11	2020-01-31	C162847	48780-1	9d75b9d0-f71b-f424-e053-dadaa90a57ce	687078d4-53d8-4e45-ab3e-375b5358d719
37205-754-36	2020-01-31	C162847	48780-1	9d75b9d0-f71b-f424-e053-dadaa90a57ce	687078d4-53d8-4e45-ab3e-375b5358d719

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-754-11	ML - Milliliter	37205-754	72ed9ba1-cbab-411d-9d61-f2949b7467de	1	2013-08-02
37205-754-36	ML - Milliliter	37205-754	2e5a8a80-8b6d-4f34-a782-50eb9fb4ef64	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	GR686LBA74	3
SODIUM PHOSPHATE, MONOBASIC	ACTIVE INGREDIENT	3980JIH2SW	3
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Leader Enema
Saline
SODIUM PHOSPHATE, DIBASIC
PHOSPHATE ION
SODIUM CATION
SODIUM PHOSPHATE, MONOBASIC
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-754	37205-754-11, 37205-754-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	ACTIB
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	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 2 · 101 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 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
9bc99ce0-a835-45b4-97b7-5fb784fda2fc			687078d4-53d8-4e45-ab3e-375b5358d719	2025-04-23	Warnings	Exact identifier spl set id: 687078d4-53d8-4e45-ab3e-375b5358d719

Reported adverse events (FAERS/openFDA)#

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