Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 8bf5f0a6-d786-457e-bedf-e30f347b98c1
Route
RECTAL
Published
Effective Date 2013-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (7 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-31

Description

(in each 118 mL delivered dose) Dibasic sodium phosphate 7 g Monobasic sodium phosphate 19 g

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

(in each 118 mL delivered dose) Dibasic sodium phosphate 7 g Monobasic sodium phosphate 19 g

Uses
  • relieves occasional constipation
Warnings

For rectal use only

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

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.

Positioning:

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

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

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.
Active Ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

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
Side and Back Box
Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

1-800-633-5463

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)

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
Side and Principal Display Panel Box

Sunmark

Compare to Fleet Enema Saline Active Ingredients

NDC 49348-005-35

Complete & Ready-to-Use

ENEMA

Saline Laxative

For relief of occasional constipation

Soft, flexible

Comfort tip

Pre-mixed

Twin Pack

Latex Free

2 bottles

4.5 FL OZ (133 ml) each

Total 9 FL OZ (266 ml)

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.


Structured Label Content

Uses
  • relieves occasional constipation
Purpose

Saline laxative

Warnings

For rectal use only

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

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.

Positioning:

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

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

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.
Active Ingredient (Active ingredient)

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

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
Side and Back Box (Side and Back - box)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

1-800-633-5463

When Using This Product (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 (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. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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
Side and Principal Display Panel Box (Side and Principal Display Panel - box)

Sunmark

Compare to Fleet Enema Saline Active Ingredients

NDC 49348-005-35

Complete & Ready-to-Use

ENEMA

Saline Laxative

For relief of occasional constipation

Soft, flexible

Comfort tip

Pre-mixed

Twin Pack

Latex Free

2 bottles

4.5 FL OZ (133 ml) each

Total 9 FL OZ (266 ml)

Ask A Doctor Or Pharmacist Before Use If You Are (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.


Advanced Ingredient Data


Raw Label Data

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