014 Pure & Gentle Saline Enema Laxative

014 Pure & Gentle Saline Enema Laxative
SPL v13
SPL
SPL Set ID e3165538-75dd-4f0f-adc8-d4075de10f1e
Route
RECTAL
Published
Effective Date 2022-04-30
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 DRUG Active Since 2014-04-09

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
  • this product generally produces bowel movement in 1 to 5 minutes
Warnings

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

For rectal use only.

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.

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

Use Pediatric Enema

children under

2 years

DO NOT USE

CAUTION: Remove protective shield from enema tip before inserting.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Positions for using this enema:

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 with left arm folded comfortably.

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side to side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus.
  • Do not force enema tip into 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.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed.
  • Remove tip from rectum and stay in 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.
Do Not Use
  • on children under 2 years of age
Package Label

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 at15-30°C (59-86°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

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
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095005

V1 RD22NPX

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal)

These symptoms may indicate a serious condition.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Ask A Doctor Before Use If You
  • 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
  • are on a sodium-restricted diet
  • have abdominal pain, nausea or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
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 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
  • this product generally produces bowel movement in 1 to 5 minutes
Purpose

Saline laxative

Warnings

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

For rectal use only.

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.

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

Use Pediatric Enema

children under

2 years

DO NOT USE

CAUTION: Remove protective shield from enema tip before inserting.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Positions for using this enema:

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 with left arm folded comfortably.

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side to side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus.
  • Do not force enema tip into 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.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed.
  • Remove tip from rectum and stay in 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.
Do Not Use (Do not use)
  • on children under 2 years of age
Package Label

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 at15-30°C (59-86°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 (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

866-323-0107

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, without asking a doctor
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095005

V1 RD22NPX

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal)

These symptoms may indicate a serious condition.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • 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
  • are on a sodium-restricted diet
  • have abdominal pain, nausea or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
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 Or Pharmacist Before Use If You (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.


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