Drug Facts

Composition & Product

Active Ingredients

Sennosides (8.6 mg) Docusate (50 mg)

Inactive Ingredients

Croscarmellose Sodium D&c Yellow No. 10 Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Sodium Benzoate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PH32 Shape: round Color: orange Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-11-27

Medication Information

Purpose

Laxative

Stool Softner

Description

Sennosides from Senna Concentrate 8.6mg Docusate Sodium 50mg

Uses

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

Section 51945-4

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

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

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 15^o-30^oC (59^o-86^oF)

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

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.

Active Ingredients (in Each Tablet)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

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

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

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

Purpose

Laxative

Stool Softner

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

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 (Other information)

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

Inactive Ingredients (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? (Questions or comments?)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast feeding,)

ask a healthcare 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 immediately.

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

[{"name": "SENNOSIDES", "unii": "3FYP5M0IJX", "classCode": "ACTIB", "strengthNumerator": "8.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• relieves occasional constipation (irregularity) • generally produces a bowel movement in 6-12 hours", "51945-4": "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", "Purpose": "Laxative Stool Softner", "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", "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 15 o -30 o C (59 o -86 o F)", "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", "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.", "Active Ingredients (in each tablet)": "Sennosides from Senna Concentrate 8.6mg Docusate Sodium 50mg", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information