DOCUZEN- sennosides 8.6mg and docusate sodium 50mg tablet

DOCUZEN by

Drug Labeling and Warnings

DOCUZEN by is a Otc medication manufactured, distributed, or labeled by Village Pharma, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

Laxative

Stool Softner

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor
• if you are taking mineral oils, unlesss directed by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• you have rectal bleeding 
• you fail to have a bowel movement after the use of a laxative.

These may indicate a serious condition.

If pregnant or breast feeding,

ask a healthcare professional before use. 

Keep out of reach of children.

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

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
Adults and children 12 years and over	2 tablets once a day	4 tablets twice a day
Children 6 to under 12 years	1 tablet once a day	2 tablets  twice a day
Children 2 to under 6 years	1/2 tablet  once a day	1 tablet twice a day
Children under 2 years	ask a doctor	ask a  doctor

Other information

• each tablet contains 10 mg of calcium, sodium 5 mg
• store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF)

Inactive ingredients

croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc & titanium dioxide.

Questions or comments?

1-800-828-0464 Mon-Fri 8 AM to 4 PM

PRINCIPAL DISPLAY PANEL

VillagePharma

NDC: 71574-700-60

DOCUZEN

Sennosides 8.6mg &

Docusate Sodium 50mg

60 TABLETS

Manufactured in the USA

INGREDIENTS AND APPEARANCE

DOCUZEN 
sennosides 8.6mg and docusate sodium 50mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71574-700
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71574-700-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/27/2018

Labeler - Village Pharma (080749749)

Registrant - Village Pharma (080749749)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(71574-700) , pack(71574-700) , analysis(71574-700)