Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d7560c7f-9366-4e09-ac24-7097f24f0746
Route
RECTAL
Published
Effective Date 2020-01-23
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

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.

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
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
Principal Display Panel 2 Bottle Carton

COMPARE TO the active ingredients of

FLEET® ENEMA SALINE *See side panel

NDC 30142-005-35

TWIN

PACK

Kroger®

OUR PHARMACIST RECOMMENDED

READY-TO-USE

Enema

SALINE LAXATIVE

Soft, Flexible Tip

For Relief of Occasional

Constipation

  • -
    Lubricated Tip for

    Comfort Application
  • -
    Pre-Mixed
  • -
    Not Made with

    Natural Rubber

    Latex

TAMPER EVIDENT

SAFETY SEALED

BOTTLES

FAST

RELIEF

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

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.

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
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
Principal Display Panel 2 Bottle Carton (PRINCIPAL DISPLAY PANEL - 2 Bottle Carton)

COMPARE TO the active ingredients of

FLEET® ENEMA SALINE *See side panel

NDC 30142-005-35

TWIN

PACK

Kroger®

OUR PHARMACIST RECOMMENDED

READY-TO-USE

Enema

SALINE LAXATIVE

Soft, Flexible Tip

For Relief of Occasional

Constipation

  • -
    Lubricated Tip for

    Comfort Application
  • -
    Pre-Mixed
  • -
    Not Made with

    Natural Rubber

    Latex

TAMPER EVIDENT

SAFETY SEALED

BOTTLES

FAST

RELIEF

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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