NDC 49348-186 Sunmark Saline Single Laxative

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

NDC Product Code 49348-186

NDC CODE: 49348-186

Proprietary Name: Sunmark Saline Single Laxative 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 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

NDC 49348-186-14

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

Price per Unit: $0.00566 per ML

NDC 49348-186-20

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

Price per Unit: $0.00566 per ML

NDC Product Information

Sunmark Saline Single Laxative with NDC 49348-186 is a 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 RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 283100.

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.

Sunmark Saline Single Laxative 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.


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.

Product Labeler Information

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

Labeler Name: Strategic Sourcing Services Llc
Labeler Code: 49348
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: 03-06-2013 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: 12-31-2021 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 - NO 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....
[Read More]

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Sunmark Saline Single Laxative Product Label Images

Sunmark Saline Single 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

Other

Drug Facts

Distributed By McKessonOne Post Street, San Francisco, CA 94104

Otc - Purpose

Active ingredients (in each 118mL delivered dose)PurposesDibasic Sodium Phosphate 7gSaline laxativeMonobasic 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 weekhave kidney diseasehave heart problemsare dehydratedare 55 years old or olderare on a sodium-restricted diet

Ask A Doctor Before Using Any Laxative If You Have

  • Abdominal pain, nausea, or vomitinga sudden change in bowel habits lasting more than 2 weeksalready 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 dosagedo not use for more than 3 days

Stop Use And Ask A Doctor If

  • You have bleedingthe condtion worsens or does not improve within 7 daysyou have no bowel movement within 30 minutes of enema useyou 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 dailyChildren 2 to under 12 years old1/2 bottle once dailyChildren under 2 yearsDO NOT USE

Other Information

  • Each 118 ml contains 4.4 g sodiumstore at 15 to 30°C (59 to 86°F)additional liquids by mouth are recommended while using this productthis product generally produces a bowel movement in 1 to 5 minutescarton 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

* Please review the disclaimer below.