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NDC 17856-6999-01 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is DOCUSATE SODIUM.

Product Information

NDC	17856-6999
Product ID	17856-6999_33bb086d-de31-4439-8566-00f1e71c4895
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stool Softener
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-6999-01 (17856699901)

Pricing Information	N/A
NDC Package Code	17856-6999-1
Billing NDC	17856699901
Package	100 POUCH in 1 BOX, UNIT-DOSE (17856-6999-1) / 1 CAPSULE, LIQUID FILLED in 1 POUCH (17856-6999-2)
Marketing Start Date	2022-09-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c16c273e-add4-4783-8b68-267721a744ef Details

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other information

each softgel contains: sodium 15 mg
store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan sorbitol

Questions or comments?

Call 1-800-616-2471

Principal Display Panel

Extra Strength

Docusate Sodium

250 mg

Stool Softener

Laxative

Softgels

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Product Label MAJOR Extra Strength Docusate Sodium 250 mg

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-6999(NDC:0904-6999)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-6999-1	100 in 1 BOX, UNIT-DOSE	09/22/2022
1	NDC:17856-6999-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	09/30/2019

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS		360804194	repack(17856-6999)

Revised: 9/2022

Document Id: 33bb086d-de31-4439-8566-00f1e71c4895

Set id: c16c273e-add4-4783-8b68-267721a744ef

Version: 2

Effective Time: 20220922