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NDC 70934-0805-30 DOK 100 mg/1 Details

DOK 100 mg/1

DOK is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Denton Pharma, Inc. dba Northwind Pharmaceuticals. The primary component is DOCUSATE SODIUM.

Product Information

NDC	70934-0805
Product ID	70934-805_c825cfae-3abf-7724-e053-2a95a90ab4db
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	DOK
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Denton Pharma, Inc. dba Northwind Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 70934-0805-30 (70934080530)

Pricing Information	N/A
NDC Package Code	70934-805-30
Billing NDC	70934080530
Package	30 CAPSULE in 1 BOTTLE, PLASTIC (70934-805-30)
Marketing Start Date	2020-11-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5585934-f7db-358a-e053-2995a90a27c2 Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so 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 a 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

take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1 to 3 softgels daily.
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

each softgel contains: sodium 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

NDC: 70934-805-30

INGREDIENTS AND APPEARANCE

DOK

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70934-805(NDC:0904-6457)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51;S77;SCU1;D2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70934-805-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2020	06/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/10/2020	06/30/2023

Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Name	Address	ID/FEI	Business Operations
Establishment
Denton Pharma, Inc. dba Northwind Pharmaceuticals		080355546	repack(70934-805)

Revised: 7/2021

Document Id: c825cfae-3abf-7724-e053-2a95a90ab4db

Set id: b5585934-f7db-358a-e053-2995a90a27c2

Version: 2

Effective Time: 20210727