Docusate Sodium by Reliable 1 Laboratories LLC / Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DOCUSATE SODIUM capsule

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

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 directed to do so by a doctor

ASK 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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

STOP USE

Stop use and ask a doctor if

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

PREGNANCY 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over	take 1 -3 softgels once daily or in divided doses
children 2 to under 12 years of age	1 softgel once daily
children under 2 years	ask a doctor

OTHER SAFETY INFORMATION

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

Inactive ingredients

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

Questions or comments ?

Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday

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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

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*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®

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Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com

PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct

NDC: 69618-043-01

Docusate Sodium 100 mg 100 SOFTGELS

STOOL SOFTENER LAXATIVE

PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct

NDC: 69618-043-10

Docusate Sodium 100 mg 1000 SOFTGELS

STOOL SOFTENER LAXATIVE

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-043
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-043-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016
2	NDC: 69618-043-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2016

Labeler - Reliable 1 Laboratories LLC (079718111)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69618-043) , analysis(69618-043)