DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC, MEDGEL PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner laxative

Uses

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

WARNINGS

Warnings

Ask a doctor before use if you have

• stomach pain, nausea or vomittiong
•  a sudden change in bowel habits that lasts more than 2 weeks

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if you

• you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
• yo need to use laxative for more than 1 week

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use

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.1(800)222-1222

Directions

take with a glass of water

• Adults and children 12 years and over:

  1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

• Children 2 to under 12 years of age:

  1 softgel daily.

• Children under 2 years of age:

  Ask a doctor

Other information

• Store at room temperature 20-25°C  (68-77°F) 
• protect from excessive humidity
• do not use this product of the safety seal under the cap is torn or missing

Inactive ingredients

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL- Valumeds Stool Softener 30 softels Bottle Labels-Single Tone

VALUMEDS TM

Compare to the active ingredient in

Dulcolax  ® Stool Softener  *

STOOL  SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief
Constipation Relief

30 SOFTGELS

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0317
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0317-3	1 in 1 CARTON	04/10/2018
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/10/2018

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(68210-0317)