CVS Pharmacy

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 118mL delivered dose)	Purpose
Dibasic Sodium Phosphate 7 g	Saline laxative
Monobasic Sodium Phosphate 19 g	Saline laxative

Use

INDICATIONS & USAGE SECTION

• relieves occasional constipation
• this product generally produces bowel movement in 1 to 5 minutes

Warnings

WARNINGS SECTION

For rectal use only.

Dosage warning

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

• on children under 2 years of age

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

• have already used a laxative for more than 3 days
• have kidney disease, have heart problems, or are dehydrated
• are 55 years of age or older
• have abdominal pain, nausea, or vomiting
• have a sudden change in bowel habits lasting more than 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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, without asking a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you have rectal bleeding
• you have no bowel movement within 30 minutes of enema use
• you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions (or as directed by a doctor)

DOSAGE & ADMINISTRATION SECTION

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

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

Adults and children 12 years of age and older	1 bottle once daily
Children 2 to under 12 years of age	Use Pediatric Enema
Children under 2 years of age	DO NOT USE

Other information

STORAGE AND HANDLING SECTION

• each 118 ml contains 4.3 g sodium
• store at 15 to 30°C (59 to 86°F)
• additional liquids by mouth are recommended while using this product
• Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-866-323-0107

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health_®

Compare to the active
ingredients in Fleet^®
Enema Saline*

NDC 59779-959-11

Ready-to-Use

Enema

SALINE LAXATIVE

• Pre-mixed
• For relief of occasional
  constipation
• Lubricated tip

4.5 FL OZ (133 mL)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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DailyMed Socrata Ingredients#

Products#

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

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

• CVS Pharmacy
• Saline Laxative
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• PHOSPHATE ION
• SODIUM CATION
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• WATER

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 3 · 175 matching rows.

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

Reported adverse events (FAERS/openFDA)#

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