STOOL SOFTENER- docusate sodium 100 mg capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

• for the 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 currently taking mineral oil, unless directed to do so 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

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
• fail to have a bowel movement occur after use

If pregnant 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 accidental overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Directions

Adults and children 12 years and over: take 1-3 softgels, preferably at bedtime

Children 2 to under 12 years of age: take 1 softgel, preferably at bedtime

Children under 2 years of age: ask a doctor

Other Information

• each softgel contains: sodium 5mg
• store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin USP, glycerin USP, polyethylene glycol 400, purified water USP, sorbitol USP

Package/Label Principal Display Panel

Docusate Sodium 100mg

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium 100 mg capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-314
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-314-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014
2	NDC: 69168-314-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/23/2014

Labeler - Allegiant Health (079501930)