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 Proficient Rx LP. 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

NDC: 71205-282-60

DOCUZEN

Sennosides 8.6mg &

Docusate Sodium 50mg

60 TABLETS

Manufactured in the USA

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

DOCUZEN 
sennosides 8.6mg and docusate sodium 50mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-282(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: 71205-282-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019
2	NDC: 71205-282-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019
3	NDC: 71205-282-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019

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

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-282) , RELABEL(71205-282)