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

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

Medication Information

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.

Active Ingredient

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

Purpose

Stool softener

Laxative

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.

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

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

Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Stool softener

Laxative

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 (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.

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

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

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