Rugby- Ducosate 1304

Rugby- Ducosate 1304
SPL v6
SPL
SPL Set ID e21d19d8-6c2d-4474-a663-dfe7e91ac320
Route
ORAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Fd&c Red No. 40 Methylparaben Poloxamer 124 Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Benzoate Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01
Description

Active Ingredients (per 5 mL) Docusate Sodium 50 mg

Medication Information

Warnings and Precautions

Warnings

Do not use when

  • abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more than one week unless directed by a doctor

Ask a doctore before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last more than two weeks

Stop use and ask doctor if

  • you have no bowel movements within 3 days
  • you have rectal bleeding
  • these could be signs of a serious condition
  • a skin rash occurs
  • you experience throat irritation
Indications and Usage

Uses

Relief of occasional constipation

Dosage and Administration

Directions

  • follow dosing directions below or use as directed by a physician
  • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in dividend dose
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • shake well before using

1 teasponnful = 5 mL

 Age  Dose
 Adults and children over 12 years of age  1 to 6 teaspoons (50 mg - 300 mg)
 Children under 12 years of age  Ask a doctor

Description

Active Ingredients (per 5 mL) Docusate Sodium 50 mg

Section 50565-1

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments? 1-800-645-2158

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use

Section 55105-1

Purpose

Stool Softener

Section 55106-9

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

Relief of occasional constipation

Dosage and Administration (34068-7)

Directions

  • follow dosing directions below or use as directed by a physician
  • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in dividend dose
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • shake well before using

1 teasponnful = 5 mL

 Age  Dose
 Adults and children over 12 years of age  1 to 6 teaspoons (50 mg - 300 mg)
 Children under 12 years of age  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use when

  • abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more than one week unless directed by a doctor

Ask a doctore before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last more than two weeks

Stop use and ask doctor if

  • you have no bowel movements within 3 days
  • you have rectal bleeding
  • these could be signs of a serious condition
  • a skin rash occurs
  • you experience throat irritation
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-645-2158

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use

Section 55105-1 (55105-1)

Purpose

Stool Softener

Section 55106-9 (55106-9)

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.156377 · Updated: 2026-03-14T23:12:00.901105