DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled

DOCUSATE SODIUM 100mg Two-Tone by

Drug Labeling and Warnings

DOCUSATE SODIUM 100mg Two-Tone by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. 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 softener

Uses

• relieves occasional constipation (irregularity)
• generally produces a 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 movements 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 to 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 5 mg
• VERY LOW SODIUM
• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water 

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-018-01

IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 15000 Capsules
NDC. No : 53345-018-02

IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 100MG TWO-TONE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-018
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red, white (Two-Tone)	Score	no score
Shape	CAPSULE (OVAL)	Size	13mm
Flavor		Imprint Code	PC18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-018-01	1 in 1 BOX	12/23/2013
1		20000 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 53345-018-02	1 in 1 BOX	12/23/2013
2		15000 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	12/23/2013

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(53345-018) , ANALYSIS(53345-018)