Oral Saline Laxative
FDA Label NDC 59779-111

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 Oral Saline Laxative (NDC 59779-111). 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 active ingredient (in each tablespoon), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablespoon)

Dibasic sodium phosphate 2.7 g

Monobasic sodium phosphate 7.2 g

Purpose

Saline laxative

Use

  • for relief of occasional constipation

Warnings

Dosage warning

Taking more than the recommended dose in 24 hours can be harmful.

Do Not Use

  • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities
  • in children under 5 years of age
  • for bowel cleansing

Ask A Doctor Before Use If You Have

  • abdominal pain, nausea, or vomiting
  • kidney disease
  • heart problems
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than a week
  • a dehydration condition

Ask A Doctor Or Pharmacist Before Use If You Are

  • on a sodium restricted diet
  • under a doctor’s care for any medical condition
  • taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If You

  • have any rectal bleeding
  • do not have a bowel movement within 6 hours
  • have any symptoms that your body is losing more fluid than you are drinking
  • have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting.
  •  These symptoms may indicate a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • use as a laxative for relief of occasional constipation
  • dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use.
  • Do not use for bowel cleansing.
  • Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon.

    • Ages (Years)

    Dosage

    Maximum Dose

    12 & Older

    3 Teaspoons

    6 or 9 Teaspoons*

    10 & 11

    3 Teaspoons*

    3 Teaspoons*

    5 to 9

    1 1/2 Teaspoons*

    1 1/2 Teaspoons*

    under 5

    Do Not Use

    Do Not Use

    •  *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD

Other Information

  • Each Teaspoon contains: sodium 556 mg
  • Saline laxatives increase retention of water in the intestine, promoting bowel movements.
  • this product generally produces a bowel movement in 30 minutes to 6 hours
  • this product is sugar free
  • do not freeze
  • store at room temperature

    • TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use.

Inactive Ingredients

Cherry flavor, glycerin, purified water, saccharin sodium, sodium benzoate

Questions

1-800-633-5463

Package/Label Principal Display Panel

FOR DIRECTIONS LIFT SIDE PANEL

CVS Health

NDC 59779-111-12

Phosphate

Oral Saline Laxative

For relief of occasional constipation

GINGER LEMON FLAVOR

1.5 fl oz (45 mL)

* Please review the disclaimer below.