drug facts

drug facts

SPL v1

SPL

SPL Set ID abecc082-4c04-4fae-b8e5-91ddc54d6e0c

Route

oral

Published

Effective Date 2014-05-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

docusate (50 mg) sennosides (8.6 mg)

Inactive Ingredients

colloidal silicon dioxide dibasic calcium phosphate dihydrate fd&c blue no. 2 fd&c red no. 40 stearic acid titanium dioxide talc hypromelloses magnesium stearate cellulose, microcrystalline

Identifiers & Packaging

Pill Appearance

Imprint: C18 Shape: round Color: orange Size: 10 mm Score: 1

Marketing Status

otc monograph not final active Since 2012-09-01

Description

Active Ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg

Medication Information

Warnings and Precautions

Warnings

Do Not Use

If you are now taking mineral oil,

unless directed by a doctor

Laxative products for longer than 1 week,

unless directed by a doctor

Active Ingredient

Active Ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Indications and Usage

Uses

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6-12 hours

Dosage and Administration

Directions - take preferably at bedtime or as directed by a doctor

Age Starting dose Maximum Dose

Adults and children 12 years of age or older 2 tablets once a day - 4 tablets twice a day

children 6 to 12 years of age - 1 tablet once a day 2 tablets twice a day

children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day

children under 2 years of age ask a doctor

Description

Active Ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg

Section 42228-7

If pregnant or breast-feeding ask a health professional before use

Section 50565-1

Keep Out of Reach of Children

In case of overdose, get medical help or contact

a Poison Control Center right away.

Section 50569-3

Ask a doctor before use if your have rectal bleeding or fail to have

a bowel movement after use of a laxative. These may be signs of

a serious condition

Section 51727-6

Enter section

Section 51945-4

Section 55105-1

Purpose

Stool Softner

Laxative

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Do Not Use

If you are now taking mineral oil,

unless directed by a doctor

Laxative products for longer than 1 week,

unless directed by a doctor

Active Ingredient (55106-9)

Active Ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Indications and Usage (34067-9)

Uses

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6-12 hours

Dosage and Administration (34068-7)

Directions - take preferably at bedtime or as directed by a doctor

Age Starting dose Maximum Dose

Adults and children 12 years of age or older 2 tablets once a day - 4 tablets twice a day

children 6 to 12 years of age - 1 tablet once a day 2 tablets twice a day

children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day

children under 2 years of age ask a doctor

Section 42228-7 (42228-7)

If pregnant or breast-feeding ask a health professional before use

Section 50565-1 (50565-1)

Keep Out of Reach of Children

In case of overdose, get medical help or contact

a Poison Control Center right away.

Section 50569-3 (50569-3)

Ask a doctor before use if your have rectal bleeding or fail to have

a bowel movement after use of a laxative. These may be signs of

a serious condition

Section 51727-6 (51727-6)

Enter section

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Stool Softner

Laxative

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "340", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SENNOSIDES", "unii": "3FYP5M0IJX", "classCode": "ACTIB", "strengthNumerator": "8.6", "strengthDenominator": "340", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "COLLOIDAL SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Relieves occasional constipation (irregularity) Generally causes a bowel movement in 6-12 hours", "34068-7": "Directions - take preferably at bedtime or as directed by a doctor Age Starting dose Maximum Dose Adults and children 12 years of age or older 2 tablets once a day - 4 tablets twice a day children 6 to 12 years of age - 1 tablet once a day 2 tablets twice a day children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years of age ask a doctor ", "34071-1": "Warnings Do Not Use If you are now taking mineral oil, unless directed by a doctor Laxative products for longer than 1 week, unless directed by a doctor", "42228-7": "If pregnant or breast-feeding ask a health professional before use", "50565-1": "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away.", "50569-3": "Ask a doctor before use if your have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition", "51727-6": "Enter section", "55105-1": "Purpose Stool Softner Laxative", "55106-9": "Active Ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:47.875234 · Updated: 2026-03-14T22:53:45.227062