Gc425 (426) - DailyMed Details

Gc425 (426)

SPL v3

SPL

SPL Set ID 1f11cf85-b094-4ca4-8b48-2d3a9093304b

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Docusate (250 mg)

Inactive Ingredients

Gelatin, Unspecified Glycerin C.i. Food Yellow 3 (free Acid) Water Fd&c Red No. 40 Polyethylene Glycol, Unspecified Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: SCU1 Shape: oval Color: red Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Docusate Sodium 250 mg

Purpose

Stool Softener

How Supplied

NDC: 71335-1677-1: 30 Capsules in a BOTTLE NDC: 71335-1677-2: 60 Capsules in a BOTTLE NDC: 71335-1677-3: 100 Capsules in a BOTTLE NDC: 71335-1677-4: 7 Capsules in a BOTTLE NDC: 71335-1677-5: 90 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Stool Softener

How Supplied

NDC: 71335-1677-1: 30 Capsules in a BOTTLE

NDC: 71335-1677-2: 60 Capsules in a BOTTLE

NDC: 71335-1677-3: 100 Capsules in a BOTTLE

NDC: 71335-1677-4: 7 Capsules in a BOTTLE

NDC: 71335-1677-5: 90 Capsules in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Docusate Sodium 250 mg

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 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 250 mg Capsule

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

adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
children under 12: do not use
do not exceed recommended dose

Other Information

each softgel contains: sodium 15 mg
store at 59°-77°F (15°-25°C)
keep tightly closed
product of Romania
Package not child resistant
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, glycerol, PEG, purified water, sorbitol special

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 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 250 mg Capsule

Purpose

Stool Softener

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

adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
children under 12: do not use
do not exceed recommended dose

How Supplied (HOW SUPPLIED)

NDC: 71335-1677-1: 30 Capsules in a BOTTLE

NDC: 71335-1677-2: 60 Capsules in a BOTTLE

NDC: 71335-1677-3: 100 Capsules in a BOTTLE

NDC: 71335-1677-4: 7 Capsules in a BOTTLE

NDC: 71335-1677-5: 90 Capsules in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

each softgel contains: sodium 15 mg
store at 59°-77°F (15°-25°C)
keep tightly closed
product of Romania
Package not child resistant
Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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

Docusate Sodium 250 mg

Advanced Ingredient Data

[{"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C.I. FOOD YELLOW 3 (FREE ACID)", "unii": "G2B7JWK1GG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 250 mg Capsule", "Purpose": "Stool Softener", "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": "adults and children 12 years and older: take 1 softgel daily or as directed by a doctor children under 12: do not use do not exceed recommended dose", "HOW SUPPLIED": "NDC: 71335-1677-1: 30 Capsules in a BOTTLE NDC: 71335-1677-2: 60 Capsules in a BOTTLE NDC: 71335-1677-3: 100 Capsules in a BOTTLE NDC: 71335-1677-4: 7 Capsules in a BOTTLE NDC: 71335-1677-5: 90 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "each softgel contains: sodium 15 mg store at 59°-77°F (15°-25°C) keep tightly closed product of Romania Package not child resistant 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, glycerol, PEG, purified water, sorbitol special", "Questions or comments?": "1-800-540-3765", "Active ingredient (in each softgel)": "Docusate Sodium 250 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:56.903096 · Updated: 2026-03-14T23:02:46.668637