DOCUSATE SODIUM capsule, liquid filled

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
OTC DRUG
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.
Authorization status:
OTC monograph not final
Authorization number:
61919-459-60

DOCUSATE SODIUM- docusate sodium capsule, liquid filled

Direct_Rx

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.

----------

DOCUSATE SODIUM

Docusate Sodium 100 mg

Purpose

Stool softener

for prevention of dry, hard stools

for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Do not use

if you are currently 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

if you notice a sudden change in bowel habits that persists 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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

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

adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime

children 6-12 years of age take 1 softgel at bedtime

children under 6 years ask a doctor

each softgel contains: sodium 6 mg

store between 15º-30ºC (59º-86ºF)

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene

glycol, purified water, sorbitol special.

1-800-645-2158

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -459 (NDC:0 536 -3756 )

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

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

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

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

GELATIN (UNII: 2G8 6 QN327L)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

o range ((o range))

S core

no sco re

S hap e

OVAL ((OVAL))

S iz e

13mm

Flavor

Imprint Code

Contains

Dire ct_Rx

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -459 -6 0

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

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 8 /14/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -459 )

Revised: 1/2020

Similar products

Search alerts related to this product

View documents history

Share this information