Fresh Prep Laxative description, usages, side effects, indications, overdosage, supplying and lots more!

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Fresh Prep Laxative

Medline Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Fresh Prep Laxative Uses

  • •relieves occasional constipation

Warnings

For rectal use only

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

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.

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

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.

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

NDC 53329-012-11

Fresh Prep ™

Saline Laxative

ENEMA

  •  Comfortable,
  •  Lubricated Tip for
  •  Easy Insertion
  •  Ready-to-Use
  •  Latex free

1 - 4.5 Fl OZ (133 ml)

Side and Back - box

Fresh Prep Laxative

sodium phosphate ENEMA

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53329-012
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM PHOSPHATE, DIBASIC 7 g
sodium phosphate, monobasic 19 g

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
EDETATE DISODIUM
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 BOTTLE
2 NDC:53329-012-11 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2012-07-16


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