Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 12f613e4-c919-4cc4-a445-eb30039ae45f

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Sennosides (8.6 mg) Docusate (50 mg)

Inactive Ingredients

Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Sodium Benzoate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-10-22

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative

How Supplied

Docusate Sodium 50 mg - Sennosides 8.6 mg NDC: 71335-2693-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-2: 120 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-3: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-4: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-5: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-6: 28 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-7: 56 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-8: 14 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-9: 20 Tablets in a BOTTLE, PLASTIC Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Stool softener

Stimulant laxative

How Supplied

Docusate Sodium 50 mg - Sennosides 8.6 mg

NDC: 71335-2693-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-2: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-3: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-4: 90 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-5: 100 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-6: 28 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-7: 56 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-8: 14 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-9: 20 Tablets in a BOTTLE, PLASTIC

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses

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

Section 51945-4

Docusate/ Sennosides 50/8.6 mg Tablet

Directions

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take upto 1 tablet daily
children under 2	ask a doctor

Do Not Use

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently taking mineral oil, unless told to do so by a doctor

Other Information

each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
store at 20-25°C (68-77°F); excursions permitted between 15-30^oC (59-86^oF). Keep tightly closed.

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If

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

These could be sings of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Docusate/ Sennosides 50/8.6 mg Tablet

Purpose

Stool softener

Stimulant laxative

Directions

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take upto 1 tablet daily
children under 2	ask a doctor

Do Not Use (Do not use)

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently taking mineral oil, unless told to do so by a doctor

How Supplied (HOW SUPPLIED)

Docusate Sodium 50 mg - Sennosides 8.6 mg

NDC: 71335-2693-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-2: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-3: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-4: 90 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-5: 100 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-6: 28 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-7: 56 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-8: 14 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2693-9: 20 Tablets in a BOTTLE, PLASTIC

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
store at 20-25°C (68-77°F); excursions permitted between 15-30^oC (59-86^oF). Keep tightly closed.

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

These could be sings of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health 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 right away (1-800-222-1222).

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

Docusate Sodium 50 mg

Sennosides 8.6 mg

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 lasts over 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": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "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": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "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 to 12 hours", "51945-4": "Docusate/ Sennosides 50/8.6 mg Tablet", "Purpose": "Stool softener Stimulant laxative", "Directions": "take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take upto 1 tablet daily children under 2 ask a doctor", "Do not use": "laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor", "HOW SUPPLIED": "Docusate Sodium 50 mg - Sennosides 8.6 mg NDC: 71335-2693-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-2: 120 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-3: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-4: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-5: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-6: 28 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-7: 56 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-8: 14 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-9: 20 Tablets in a BOTTLE, PLASTIC Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium store at 20-25°C (68-77°F); excursions permitted between 15-30 o C (59-86 o F). Keep tightly closed. ", "Inactive ingredients": "croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide", "Questions or comments?": "(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)", "Stop use and ask a doctor if": "you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These could be sings of a serious condition.", "If pregnant or breast-feeding,": "ask a health professional before use. ", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "Active Ingredients (in each tablet)": "Docusate Sodium 50 mg Sennosides 8.6 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:02.597120 · Updated: 2026-03-14T23:10:13.362427