DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

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

Uses

• For the relief of occasional constipation.
• Helps to prevent dry, hard stools.
• 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 by a doctor.
• When abdominal pain, nausea, or vomiting are present.
• For longer than one 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 two weeks.

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare professional before use.

Directions

• Adults and Children over 12 years of age: Take orally 1 softgel preferably at bedtime for ; 2-3 days or until bowel movements are normal, or as directed by a doctor.
• Children under 12 years of age: Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

• Each softgel contains 13 mg of Sodium.                    
• Store at room temperature between 15°C to 30°C (59°F to 86°F).
• Do not use if printed seal under cap is broken or missing.
• For identification purposes, each softgel will have an imprint that reads NV12.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions

Call 1-855-361-3993

Package/Label Principal Display Panel

NDC: 50268-268-15
AvKARE
Docusate Sodium, USP
Stool Softener
250 mg Each
100 Softgels


USA
AV Rev. 05/16 (P)
                

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478                  

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-268(NDC:54629-601)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	NV12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-268-15	50 in 1 BOX	05/17/2017
1	NDC: 50268-268-11	1 in 1 BLISTER PACK; 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	05/17/2017

Labeler - AvPAK (832926666)