DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by AiPing Pharmaceutical, Inc., Anshi Pharmaceutical (Zhongshan) Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Docusate Sodium 100 mg

PURPOSE

Stool softener

USES

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

WARNINGS

Do Not Use

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

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 and over: take 1-3 softgels daily

Children 2 to under 12 years of age: take 1 softgel daily

Children under 2 years: ask a doctor

OTHER INFORMATION

• each softgel contains: sodium 6 mg
• Store at room temperature 15-30°C

INACTIVE INGREDIENTS

Black edible ink, D&C Red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

PRINCIPAL DISPLAY PANEL-SHIPPING LABEL

Docusate Sodium Softgels, USP 100mg (Double-Tone)

Quantity : 19000 Softgels

NDC. No : 11788-015-00

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11788-015
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	red (Double-Tone: white and clear red)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	AP015
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11788-015-00	1 in 1 BOX	11/01/2018
1		19000 in 1 BAG; 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	11/01/2018

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Establishment
Name	Address	ID/FEI	Business Operations
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-015) , analysis(11788-015) , label(11788-015) , pack(11788-015)