DOCUZEN- sennosides 8.6mg and docusate sodium 50mg tablet 
Village Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

VillagePharma

NDC 71574-700-60

DOCUZEN

Sennosides 8.6mg &

Docusate Sodium 50mg

60 TABLETS

Manufactured in the USA

image of Label
DOCUZEN 
sennosides 8.6mg and docusate sodium 50mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
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
Colororange (ORANGE COLOR) Scoreno score
ShapeROUND (ROUND TABLET) Size10mm
FlavorImprint Code PH32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71574-700-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/27/2018
Labeler - Village Pharma (080749749)
Registrant - Village Pharma (080749749)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(71574-700) , pack(71574-700) , analysis(71574-700)

Revised: 11/2018
Document Id: 29102014-9b0e-4899-958d-83111f94a612
Set id: 29102014-9b0e-4899-958d-83111f94a612
Version: 1
Effective Time: 20181127
 
Village Pharma