NDC 17856-0398 Stool Softener Liquid

NDC Product Code 17856-0398

NDC 17856-0398-1

Package Description: 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 25 mL in 1 CUP, UNIT-DOSE

NDC 17856-0398-2

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 10 mL in 1 CUP, UNIT-DOSE

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Stool Softener Liquid with NDC 17856-0398 is a product labeled by Atlantic Biologicals Corp.. The generic name of Stool Softener Liquid is . The product's dosage form is and is administered via form.

Labeler Name: Atlantic Biologicals Corp.

Dosage 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.

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SUCROSE (UNII: C151H8M554)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

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

Labeler Name: Atlantic Biologicals Corp.
Labeler Code: 17856
Start Marketing Date: 09-01-2017 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: E 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.

Stool Softener Liquid Product Label Images

Stool Softener Liquid 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 5 Ml Teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 12 to 72 hours

Warnings

  • Do not use for more than one week unless directed by a doctor
  • Ask a doctor before use if youhave abdominal pain, nausea, or vomitingare taking mineral oilhave noticed a sudden change in bowel habits that lasts more than 14 daysStop use and ask a doctor ifyou have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.a skin rash occursyou experience throat irritation

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. In case of overdose, get medical help or contact a poison control Center right away.

Directions

  • Follow dosing directions below or take as directed by doctormust be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritationmay be taken as a single daily dose or in divided dosestake maximum daily dose until first bowel movement, then reduce dose according to individual responseshake well before usingAdults and children 12 years and over
  • 1 to 4 teaspoonfuls (5 to 20 mL)
  • Children under 12 years of age
  • Ask a doctor

Other Information

  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)protect from excessive heatKeep tightly closed

Inactive Ingredients

Citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.20101 N.E 16TH PLACE MIAMI, FL 33179

Package Label

NDC 17856-0398-1Compare to Colace® Liquid active ingredient *GOOD NEIGHBOR PHARMACYSTOOL SOFTENER LIQUID Docusate Sodium Relieves Constipation 250mg/25 mL 50 cups per caseNDC 17856-0398-2Compare to Colace® Liquid active ingredient *GOOD NEIGHBOR PHARMACYSTOOLSOFTENERLIQUIDDocusate SodiumRelieves Constipation100mg/10 mL72 cups per case

* Please review the disclaimer below.