Cvs Pharmacy
FDA Label NDC 59779-969

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Pharmacy (NDC 59779-969). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, dosage warning, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

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

Use

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

Warnings

For rectal use only.

Dosage Warning

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

Otc - Ask Doctor

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

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

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

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

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)

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 years1 bottle once daily
children under 2 yearsask a doctor

Other Information

  • 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

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 66 Ml Bottle Carton

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)

    Principal Display Panel (66 mL Bottle Carton)

    Principal Display Panel (66 mL Bottle Carton)

* Please review the disclaimer below.