NDC 62011-0191 Saline Laxative

NDC Product Code 62011-0191

NDC 62011-0191-1

Package Description: 1 BOTTLE in 1 BOX > 133 mL in 1 BOTTLE

Price per Unit: $0.00588 per ML

NDC 62011-0191-2

Package Description: 2 BOTTLE in 1 BOX > 133 mL in 1 BOTTLE

Price per Unit: $0.00602 per ML

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Saline Laxative with NDC 62011-0191 is a product labeled by Mckesson. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 283100.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson
Labeler Code: 62011
Start Marketing Date: 08-22-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Sodium Phosphate Rectal

Sodium Phosphate Rectal is pronounced as (soe' dee um) (fos' fate)

Why is sodium phosphate rectal medication prescribed?
Rectal sodium phosphate is used to treat constipation that happens from time to time. Rectal sodium phosphate should not be given to children younger than 2 years of age....
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Saline Laxative Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

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

Purpose

Saline laxative

Uses

  • •relieves occasional constipation

Warnings

For rectal use only

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.

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 overone bottle once dailychildren 2 to under12 years1/2 bottle once dailychildren under2 yearsdo not useCAUTION: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

* Please review the disclaimer below.