DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• for relief of occasional constipation (irregularity)
• 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 unless directed by a doctor
• 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 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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.

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years of age and over:

  take 1 to 3 softgels daily

• children 2 to under 12 years of age:

  take 1 softgel daily

• children under 2 years of age:

  ask a doctor

Other information

• Each softgel contains: sodium 7 mg VERY LOW SODIUM
• Store at room temperature between 15° to 30°C (59° to 86°F)
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

712901
0412901/0216PS

Principal Display Panel – Carton – 100 mg

NDC 60687- 129-01

DOCUSATE SODIUM, USP
Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from
NDC # 61301-8001, SWISSCAPS Romania srl.

Packaged and Distributed by:
American Health Packaging
Columbus, OH 43217

712901
0412901/0119

Principal Display Panel - Blister – 100 mg

DOCUSATE SODIUM, USP
Stool Softener Laxative
Softgel 100 mg

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-129
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-129-01	100 in 1 BOX, UNIT-DOSE	11/25/2015
1	NDC: 60687-129-11	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	11/25/2015

Labeler - American Health Packaging (929561009)

Registrant - Swiss Caps Romania (565466997)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps Romania		565466997	manufacture(60687-129)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-129)