STOOL SOFTENER

Main information

  • Trade name:
  • STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled
  • Composition:
  • DOCUSATE SODIUM 200 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ■ for prevention of dry, hard stools ■ for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 70005-015-02, 70005-015-25, 70005-015-50
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled

We Care Distributor Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

STOOL SOFTENER - Docusate Sodium Softgels, 100 mg

Drug Facts

Active ingredient (in each softgel) Purpose

Docusate sodium 100 mg..............................Stool softener

Us es

■ for prevention of dry, hard stools

■ 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

■ when abdominal pain, nausea, or vomiting are present

■ for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

■ you have rectal bleeding

■ you fail to have a bowel movement after use

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 with a glass of water

■ adults and children 12 years of age and over: take 1 to 3 softgels daily. This dose may be taken as

single daily dose or in divided doses.

■ children 2 to under 12 years of age: take 1 softgels daily

■ children under 2 years of age: consult a physician.

Other information

■ each softgel contains sodium 6 mg

■ store at controlled room temperature 15°-30°C (59°-86°F)

■ read all product information before using

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol,

purified water, sorbitol solution, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Dulcolax® Stool Softener

STOOL SOFTENER

Docusate Sodium Softgels, 100 mg

TO OPEN

PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgels Each

STOOL SOFTENER

docusate sodium 100 mg capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 5-0 15

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)

DOCUSATE SODIUM

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

re d

S core

no sco re

S hap e

OVAL

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 5-0 15-25

25 in 1 BOX

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:70 0 0 5-0 15-50

50 in 1 BOX

2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:70 0 0 5-0 15-0 2

2 in 1 POUCH

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 3/0 7/20 16

Labeler -

We Care Distributor Inc. (079832998)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MEDGEL PVT LTD

6 7738 549 8

ma nufa c ture (70 0 0 5-0 15)

We Care Distributor Inc.

Revised: 3/2016