Gc 455t (458)

SPL v3

SPL

SPL Set ID 5f3b3624-f7a7-4cdf-8c23-d1bdea9b8038

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sennosides (8.6 mg) Docusate (50 mg)

Inactive Ingredients

Microcrystalline Cellulose Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Silicate Magnesium Stearate Mineral Oil Polyethylene Glycol, Unspecified Hypromellose, Unspecified Fd&c Yellow No. 5 Fd&c Yellow No. 6 Sodium Benzoate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Titanium Dioxide Triacetin Carnauba Wax D&c Yellow No. 10 Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: TCL081 Shape: round Color: orange Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2000-01-01 Until 2025-10-31

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative

How Supplied

Docusate Sodium 50 mg - Sennosides 8.6 mg NDC 71335-1181-1: 30 Tablets in a BOTTLE NDC 71335-1181-2: 120 Tablets in a BOTTLE NDC 71335-1181-3: 60 Tablets in a BOTTLE NDC 71335-1181-4: 90 Tablets in a BOTTLE NDC 71335-1181-5: 100 Tablets in a BOTTLE NDC 71335-1181-6: 28 Tablets in a BOTTLE NDC 71335-1181-7: 56 Tablets in a BOTTLE NDC 71335-1181-8: 14 Tablets in a BOTTLE NDC 71335-1181-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Stool softener

Laxative

How Supplied

Docusate Sodium 50 mg - Sennosides 8.6 mg

NDC 71335-1181-1: 30 Tablets in a BOTTLE
NDC 71335-1181-2: 120 Tablets in a BOTTLE
NDC 71335-1181-3: 60 Tablets in a BOTTLE
NDC 71335-1181-4: 90 Tablets in a BOTTLE
NDC 71335-1181-5: 100 Tablets in a BOTTLE
NDC 71335-1181-6: 28 Tablets in a BOTTLE
NDC 71335-1181-7: 56 Tablets in a BOTTLE
NDC 71335-1181-8: 14 Tablets in a BOTTLE
NDC 71335-1181-9: 20 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses

relieves occasional constipation (irregularity)

this product generally produces a bowel movement in 6 to 12 hours

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 51945-4

Docusate Sodium 50 mg - Sennosides 8.6 mg Tablet

Warnings

Do not usefor more than 1 week unless directed by a doctor

Ask a doctor before use if you

have abdominal pain, nausea or vomiting
are taking mineral oil
have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have

no bowel movement within 12 hours
rectal bleeding
these could signs of a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor	4 tablets in the morning and 4 tablets at bedtime
children under 12 years	ask a doctor

Other Information

each tablet contains:calcium 20 mg, sodium 6 mg
Tamper Evident:Do not use if imprinted seal under cap is missing or broken.
store at room temperature

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

Active Ingredient (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Structured Label Content

Uses

relieves occasional constipation (irregularity)

this product generally produces a bowel movement in 6 to 12 hours

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 51945-4 (51945-4)

Docusate Sodium 50 mg - Sennosides 8.6 mg Tablet

Purpose

Stool softener

Laxative

Warnings

Do not usefor more than 1 week unless directed by a doctor

Ask a doctor before use if you

have abdominal pain, nausea or vomiting
are taking mineral oil
have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have

no bowel movement within 12 hours
rectal bleeding
these could signs of a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor	4 tablets in the morning and 4 tablets at bedtime
children under 12 years	ask a doctor

How Supplied (HOW SUPPLIED)

Docusate Sodium 50 mg - Sennosides 8.6 mg

NDC 71335-1181-1: 30 Tablets in a BOTTLE
NDC 71335-1181-2: 120 Tablets in a BOTTLE
NDC 71335-1181-3: 60 Tablets in a BOTTLE
NDC 71335-1181-4: 90 Tablets in a BOTTLE
NDC 71335-1181-5: 100 Tablets in a BOTTLE
NDC 71335-1181-6: 28 Tablets in a BOTTLE
NDC 71335-1181-7: 56 Tablets in a BOTTLE
NDC 71335-1181-8: 14 Tablets in a BOTTLE
NDC 71335-1181-9: 20 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

each tablet contains:calcium 20 mg, sodium 6 mg
Tamper Evident:Do not use if imprinted seal under cap is missing or broken.
store at room temperature

Inactive Ingredients (Inactive ingredients)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SILICATE", "unii": "9B9691B2N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "51945-4": "Docusate Sodium 50 mg - Sennosides 8.6 mg Tablet", "Purpose": "Stool softener Laxative", "Warnings": "Do not use for more than 1 week unless directed by a doctor Ask a doctor before use if you have abdominal pain, nausea or vomiting are taking mineral oil have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have no bowel movement within 12 hours rectal bleeding these could signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.", "Directions": "• do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor", "HOW SUPPLIED": "Docusate Sodium 50 mg - Sennosides 8.6 mg NDC 71335-1181-1: 30 Tablets in a BOTTLE NDC 71335-1181-2: 120 Tablets in a BOTTLE NDC 71335-1181-3: 60 Tablets in a BOTTLE NDC 71335-1181-4: 90 Tablets in a BOTTLE NDC 71335-1181-5: 100 Tablets in a BOTTLE NDC 71335-1181-6: 28 Tablets in a BOTTLE NDC 71335-1181-7: 56 Tablets in a BOTTLE NDC 71335-1181-8: 14 Tablets in a BOTTLE NDC 71335-1181-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "each tablet contains: calcium 20 mg, sodium 6 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken. store at room temperature", "Inactive ingredients": "cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.", "Active ingredient (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: 2026-02-15T12:06:01.340348 · Updated: 2026-03-14T23:08:29.204921