NDC 69626-0085 Reflief Saline Laxative Pediatric Ready To Use

Sodium Phosphate, Dibasic, Unspecified Form And Sodium Phosphate, Monobasic, Unspecified Form

NDC Product Code 69626-0085

NDC CODE: 69626-0085

Proprietary Name: Reflief Saline Laxative Pediatric Ready To Use What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Phosphate, Dibasic, Unspecified Form And Sodium Phosphate, Monobasic, Unspecified Form What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 69626 - Leosons Overseas Corp
    • 69626-0085 - Reflief Saline Laxative Pediatric Ready To Use

NDC 69626-0085-7

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 67 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Reflief Saline Laxative Pediatric Ready To Use with NDC 69626-0085 is a a human over the counter drug product labeled by Leosons Overseas Corp. The generic name of Reflief Saline Laxative Pediatric Ready To Use is sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form. The product's dosage form is enema and is administered via rectal form.

Labeler Name: Leosons Overseas Corp

Dosage Form: Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Reflief Saline Laxative Pediatric Ready To Use Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 3.5 g/59mL
  • SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 9.5 g/59mL

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: Leosons Overseas Corp
Labeler Code: 69626
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-01-2019 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: 12-31-2020 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Reflief Saline Laxative Pediatric Ready To Use Product Label Images

Reflief Saline Laxative Pediatric Ready To Use 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

Other

Drug Facts

Distributed by:Leosons 10 Maryland Avenue Albany, New York 12205

Otc - Purpose

Active ingredients (in each 59 ml delivered dose)PurposeDibasic Sodium Phosphate 3.5gSaline laxativeMonobasic Sodium Phosphate 9.5gSaline laxative

Use

  • Relieves occasional constipationthis product generally produces bowel movement in 1 to 5 minutes

Warnings

For rectal use only.

Dosage Warning

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

Do Not Use

  • On children under 2 years of age

Otc - Ask Doctor

  • Ask a doctor before use if the childhas already used a laxative for more than 3 dayshas kidney disease, have heart problems, or are dehydratedis on a sodium-restricted diethas abdominal pain, nausea, or vomitinghas a sudden change in bowel habits lasting more than 2 weeks

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is 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 dosagedo not use for more than 3 days, without asking a doctor

Otc - Stop Use

  • Stop use and ask a doctor if the childhas rectal bleedinghas no bowel movement within 30 minutes of enema usehas symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

Otc - 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: 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.children 2 to under 12 years of ageUse 1 bottle once dailychildren under 2 years of ageDO NOT USE

Other Information

  • Each 59 mL contains 2.2g sodiumstore at 15 to 30°C (59 to 86°F)additional liquids by mouth are recommended while using this productTamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

* Please review the disclaimer below.