NDC 49348-186 Sunmark Saline Single Laxative
Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form Enema Recta...

Product Information

What is NDC 49348-186?

The NDC code 49348-186 is assigned by the FDA to the product Sunmark Saline Single Laxative which is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark Saline Single Laxative is sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form. The product's dosage form is enema and is administered via rectal form. The product is distributed in 2 packages with assigned NDC codes 49348-186-14 2 bottle in 1 carton / 133 ml in 1 bottle, 49348-186-20 1 bottle in 1 carton / 133 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code49348-186
Proprietary Name 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.
Sunmark Saline Single Laxative
Non-Proprietary Name 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.
Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form
Product Type 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.
Human Otc Drug
Dosage FormEnema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Strategic Sourcing Services Llc
Labeler Code49348
FDA Application Number 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.
part334
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-06-2013
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Sunmark Saline Single Laxative?


Product Packages

NDC Code 49348-186-14

Package Description: 2 BOTTLE in 1 CARTON / 133 mL in 1 BOTTLE

Price per Unit: $0.00587 per ML

NDC Code 49348-186-20

Package Description: 1 BOTTLE in 1 CARTON / 133 mL in 1 BOTTLE

Price per Unit: $0.00606 per ML

Product Details

What are Sunmark Saline Single Laxative Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Sunmark Saline Single Laxative Active Ingredients UNII Codes

  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • PHOSPHATE ION (UNII: NK08V8K8HR) (Active Moiety)
  • SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
  • SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema

Sunmark Saline Single Laxative Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Patient Education

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....
[Read More]

* Please review the disclaimer below.

Sunmark Saline Single Laxative Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Distributed By McKesson
One Post Street, San Francisco, CA 94104


Otc - Purpose



Active ingredients
(in each 118mL delivered dose)
Purposes
Dibasic Sodium Phosphate 7gSaline laxative
Monobasic Sodium Phosphate 19gSaline laxative

Use



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



  • already used a laxative for more than 1 week
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet

Ask A Doctor Before Using Any Laxative If You Have



  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

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 bleeding
  • the condtion worsens or does not improve within 7 days
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
  • These symptoms may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


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



Single daily dosage (per 24 hours)

Do not use more unless directed by a doctor.

See Warnings.

Do not use if taking another sodium phosphate product.

Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other Information



  • each 118 ml contains 4.4 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1 to 5 minutes
  • carton sealed for safety. Do not use if top or bottom flap of the carton is torn or missing

Inactive Ingredients



benzalkonium chloride, disodium EDTA, purified water


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 133 Ml Bottle Carton



sunmark®

COMPARE TO
FLEET® ENEMA SALINE
ACTIVE INGREDIENTS*

NDC 49348-186-20

complete &
ready-to-use

enema

Saline Laxative

For relief of
occasional constipation

Soft, flexible
Comfort tip

Pre-mixed

Protective shield
prevents
contamination

Comfortable,
lubricated tip for
ease of insertion

One-way safety valve
controls flow and
prevents reflux

Easy, soft squeeze
bottle

LATEX FREE

4.5 FL OZ
(133 ml)


* Please review the disclaimer below.