gc 401 - DailyMed Details

gc 401

SPL v8

SPL

SPL Set ID 2c9a1fe7-b77b-436b-8701-9f95f642d001

Route

oral

Published

Effective Date 2024-07-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

docusate (100 mg)

Inactive Ingredients

fd&c red no. 40 gelatin, unspecified glycerin polyethylene glycol 400 sorbitol water fd&c yellow no. 6 mannitol

Identifiers & Packaging

Pill Appearance

Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1

Marketing Status

otc monograph drug active Since 2000-01-01

Purpose

Stool Softener Laxative

How Supplied

Docusate Sodium 100mg Capsule NDC: 71335-0294-1: 30 Tablets in a BOTTLE NDC: 71335-0294-2: 100 Tablets in a BOTTLE NDC: 71335-0294-3: 60 Tablets in a BOTTLE NDC: 71335-0294-4: 120 Tablets in a BOTTLE NDC: 71335-0294-5: 90 Tablets in a BOTTLE NDC: 71335-0294-6: 180 Tablets in a BOTTLE NDC: 71335-0294-7: 10 Tablets in a BOTTLE NDC: 71335-0294-8: 28 Tablets in a BOTTLE NDC: 71335-0294-9: 56 Tablets in a BOTTLE NDC: 71335-0294-0: 18 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Description

Docusate Sodium 100 mg

Medication Information

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Purpose

Stool Softener Laxative

Directions

• do not exceed recommended dose

• adults and children 12 years and older: take 1-3

softgels daily until first bowel movement; 1 softgel

daily thereafter, or as directed by a doctor

• children under 12: consult a doctor

Other Information

• each softgel contains: sodium 7 mg. Very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken.

Inactive Ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

How Supplied

Docusate Sodium 100mg Capsule

NDC: 71335-0294-1: 30 Tablets in a BOTTLE
NDC: 71335-0294-2: 100 Tablets in a BOTTLE
NDC: 71335-0294-3: 60 Tablets in a BOTTLE
NDC: 71335-0294-4: 120 Tablets in a BOTTLE
NDC: 71335-0294-5: 90 Tablets in a BOTTLE
NDC: 71335-0294-6: 180 Tablets in a BOTTLE
NDC: 71335-0294-7: 10 Tablets in a BOTTLE
NDC: 71335-0294-8: 28 Tablets in a BOTTLE
NDC: 71335-0294-9: 56 Tablets in a BOTTLE
NDC: 71335-0294-0: 18 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Docusate Sodium 100 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 Sodium 100mg Capsule

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Purpose

Stool Softener Laxative

Directions

Other Information (Other information)

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

How Supplied (HOW SUPPLIED)

Docusate Sodium 100mg Capsule

NDC: 71335-0294-1: 30 Tablets in a BOTTLE
NDC: 71335-0294-2: 100 Tablets in a BOTTLE
NDC: 71335-0294-3: 60 Tablets in a BOTTLE
NDC: 71335-0294-4: 120 Tablets in a BOTTLE
NDC: 71335-0294-5: 90 Tablets in a BOTTLE
NDC: 71335-0294-6: 180 Tablets in a BOTTLE
NDC: 71335-0294-7: 10 Tablets in a BOTTLE
NDC: 71335-0294-8: 28 Tablets in a BOTTLE
NDC: 71335-0294-9: 56 Tablets in a BOTTLE
NDC: 71335-0294-0: 18 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 Sodium 100mg Capsule

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 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 100mg Capsule", "Purpose": "Stool Softener Laxative", "Warnings": "Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.", "Directions": "• do not exceed recommended dose • adults and children 12 years and older: take 1-3 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult a doctor", "HOW SUPPLIED": "Docusate Sodium 100mg Capsule NDC: 71335-0294-1: 30 Tablets in a BOTTLE NDC: 71335-0294-2: 100 Tablets in a BOTTLE NDC: 71335-0294-3: 60 Tablets in a BOTTLE NDC: 71335-0294-4: 120 Tablets in a BOTTLE NDC: 71335-0294-5: 90 Tablets in a BOTTLE NDC: 71335-0294-6: 180 Tablets in a BOTTLE NDC: 71335-0294-7: 10 Tablets in a BOTTLE NDC: 71335-0294-8: 28 Tablets in a BOTTLE NDC: 71335-0294-9: 56 Tablets in a BOTTLE NDC: 71335-0294-0: 18 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "• each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.", "Inactive ingredients": "FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.199324 · Updated: 2026-03-14T23:03:12.694901