Saline Laxative
FDA Label NDC 41520-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Saline Laxative (NDC 41520-005). 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, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

  • relieves occasional constipation

Warnings

For rectal use only

Ask A Doctor Before Use If You Have

  • 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

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

  • 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

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

    • These may be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

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

1/2 bottle once daily

Discard unused portion

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.

Remove Protective Shield Illustration (7360455a 2870 4421 86d9 F83c7e780a14 04)

Remove Protective Shield Illustration (7360455a 2870 4421 86d9 F83c7e780a14 04)

Positioning:

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

Left Side Position Illustration (7360455a 2870 4421 86d9 F83c7e780a14 03)

Left Side Position Illustration (7360455a 2870 4421 86d9 F83c7e780a14 03)

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Knee-chest Position Illustration (7360455a 2870 4421 86d9 F83c7e780a14 02)

Knee-chest Position Illustration (7360455a 2870 4421 86d9 F83c7e780a14 02)

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 unit 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 the 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

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

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

1-800-633-5463

Side And Principal Display Panel - Box

Care One Saline Enema Principal Display Panel (7360455a 2870 4421 86d9 F83c7e780a14 01)

Care One Saline Enema Principal Display Panel (7360455a 2870 4421 86d9 F83c7e780a14 01)

NDC 41520-005-11

Compare to the active ingredients in Fleet® Enema Saline

Care One

Ready-to-Use

ENEMA

Saline Laxative

Latex Free

For relief of occasional constipation

Single Pack

Soft, Flexible comfort tip

Tamper Evident Seals for Safety

4.5 FL OZ (133 ml)

* Please review the disclaimer below.