CVS Pharmacy

Label at a glance#

Contacts and useful links#

PhonePoison Help800-222-1222

PhoneLabel contact866-323-0107

Websitewww.natureplex.comwww.natureplex.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 59 mL delivered dose)	Purpose
Dibasic Sodium Phosphate 3.5g	Saline laxative
Monobasic Sodium Phosphate 9.5g	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.

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before using if the child

• 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.

OTC - WHEN USING SECTION

When using this product

• 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

OTC - STOP USE SECTION

Stop use and ask a doctor if the child

• has rectal bleeding
• has no bowel movement within 30 minutes of enema use
• has symptoms of dehydration (thirstiness, dizzyness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

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

DOSAGE & ADMINISTRATION SECTION

(or as directed by a doctor)

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.

children 2 to 11 years	1 bottle once daily
children under 2 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each 59 mL contains: sodium 2.2g
• 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

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health_™

Compare to the active
ingredients in Fleet^®
Pedia-Lax Enema*

NDC 59779-969-40

Children's

Ready-to-Use

Enema

SALINE LAXATIVE

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

AGES
2-11

2.25 FL OZ (66 mL)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

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 2 · 101 matching rows.

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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.

Reported adverse events (FAERS/openFDA)#

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