Pure And Gentle Laxative Enema
FDA Label NDC 53329-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Pure And Gentle Laxative (NDC 53329-014). 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, do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if you, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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
  • 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.

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

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, without asking a doctor

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.

Keep Out Of Reach Of Children.

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

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.

Remove Protective Shield Illustration (Image 01)

Remove Protective Shield Illustration (Image 01)

Positions for using this enema:

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

Left Side Position Illustration (Image 02)

Left Side Position Illustration (Image 02)

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

Knee-chest Position Illustration (Image 03)

Knee-chest Position Illustration (Image 03)

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.
  • (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 and children 12 years old and older1 bottle once daily
    Children 2 to under 12 years oldUse Pediatric Enema
    Children under 2 yearsDO 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.

    Remove Protective Shield Illustration (Image 01)

    Remove Protective Shield Illustration (Image 01)

    Positions for using this enema:

    Left-side position:
    Lie on left side with knees bent and arms resting comfortably.

    Left Side Position Illustration (Image 02)

    Left Side Position Illustration (Image 02)

    Knee-chest position:
    Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

    Knee-chest Position Illustration (Image 03)

    Knee-chest Position Illustration (Image 03)

    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 bottle completely, as it contains more 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.

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

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