Hst 455b (555)

SPL v3

SPL

SPL Set ID 7f8396e7-07f0-4c9c-be8a-9dc00139cb83

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 Stearate Polyethylene Glycol, Unspecified Hypromellose, Unspecified Fd&c Yellow No. 6 Titanium Dioxide Talc Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PSD22 Shape: round Color: orange Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-05-01

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative

How Supplied

NDC: 71335-1674-1: 30 Tablets in a BOTTLE NDC: 71335-1674-2: 120 Tablets in a BOTTLE NDC: 71335-1674-3: 60 Tablets in a BOTTLE NDC: 71335-1674-4: 90 Tablets in a BOTTLE NDC: 71335-1674-5: 100 Tablets in a BOTTLE NDC: 71335-1674-6: 28 Tablets in a BOTTLE NDC: 71335-1674-7: 56 Tablets in a BOTTLE NDC: 71335-1674-8: 14 Tablets in a BOTTLE NDC: 71335-1674-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Stool softener

Laxative

How Supplied

NDC: 71335-1674-1: 30 Tablets in a BOTTLE

NDC: 71335-1674-2: 120 Tablets in a BOTTLE

NDC: 71335-1674-3: 60 Tablets in a BOTTLE

NDC: 71335-1674-4: 90 Tablets in a BOTTLE

NDC: 71335-1674-5: 100 Tablets in a BOTTLE

NDC: 71335-1674-6: 28 Tablets in a BOTTLE

NDC: 71335-1674-7: 56 Tablets in a BOTTLE

NDC: 71335-1674-8: 14 Tablets in a BOTTLE

NDC: 71335-1674-9: 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/ Sennosides 50/8.6 mg Tablet

Warnings

Do not use for more than one 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 two weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These may indicate 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 3 mg
store at controlled room temperature

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
product of India

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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/ Sennosides 50/8.6 mg Tablet

Purpose

Stool softener

Laxative

Warnings

Do not use for more than one 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 two weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These may indicate 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)

NDC: 71335-1674-1: 30 Tablets in a BOTTLE

NDC: 71335-1674-2: 120 Tablets in a BOTTLE

NDC: 71335-1674-3: 60 Tablets in a BOTTLE

NDC: 71335-1674-4: 90 Tablets in a BOTTLE

NDC: 71335-1674-5: 100 Tablets in a BOTTLE

NDC: 71335-1674-6: 28 Tablets in a BOTTLE

NDC: 71335-1674-7: 56 Tablets in a BOTTLE

NDC: 71335-1674-8: 14 Tablets in a BOTTLE

NDC: 71335-1674-9: 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 3 mg
store at controlled room temperature

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
product of India

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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 STEARATE", "unii": "70097M6I30", "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. 6", "unii": "H77VEI93A8", "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": "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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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/ Sennosides 50/8.6 mg Tablet", "Purpose": "Stool softener Laxative", "Warnings": "Do not use for more than one 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 two weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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": "NDC: 71335-1674-1: 30 Tablets in a BOTTLE NDC: 71335-1674-2: 120 Tablets in a BOTTLE NDC: 71335-1674-3: 60 Tablets in a BOTTLE NDC: 71335-1674-4: 90 Tablets in a BOTTLE NDC: 71335-1674-5: 100 Tablets in a BOTTLE NDC: 71335-1674-6: 28 Tablets in a BOTTLE NDC: 71335-1674-7: 56 Tablets in a BOTTLE NDC: 71335-1674-8: 14 Tablets in a BOTTLE NDC: 71335-1674-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "each tablet contains: calcium 20 mg, sodium 3 mg store at controlled room temperature Tamper Evident: Do not use if imprinted seal under cap is missing or broken. product of India", "Inactive ingredients": "cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.", "Active ingredient (in each tablet)": "Docusate Sodium 50 mg Sennosides 8.6 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:56.931575 · Updated: 2026-03-14T23:02:46.668637