Gericare- Ducosate 413

Gericare- Ducosate 413
SPL v6
SPL
SPL Set ID e50558e1-f0c8-4b03-9109-6a273b61730d
Route
ORAL
Published
Effective Date 2021-07-04
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 for more than one week unless directed by a doctor.

Ask a doctore before use if you

  • have stomach pain, nausea or vomiting
  • hadve sudden change in bowel habits that persits over a period of 2 weeks
  • are taking mineral oil

Stop use and ask doctor if

  • you have rectal bleeding or fail to have a bowel movement afrer use of this product. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation
Indications and Usage

Uses

  • Relief of occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage and Administration

Directions

shake well before using

  • follow dosing directions below or use as directed by a physician
  • do not exceed recommended dose
  • 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

1 teasponnful = 5 mL

 Age  Dose
 Adults and children over 12 years of age  1 to 6 teaspoons (5 mL - 30 mL)
 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, sodium benzoate, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments?1-800-540-3765

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 (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage and Administration (34068-7)

Directions

shake well before using

  • follow dosing directions below or use as directed by a physician
  • do not exceed recommended dose
  • 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

1 teasponnful = 5 mL

 Age  Dose
 Adults and children over 12 years of age  1 to 6 teaspoons (5 mL - 30 mL)
 Children under 12 years of age  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctore before use if you

  • have stomach pain, nausea or vomiting
  • hadve sudden change in bowel habits that persits over a period of 2 weeks
  • are taking mineral oil

Stop use and ask doctor if

  • you have rectal bleeding or fail to have a bowel movement afrer use of this product. 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, sodium benzoate, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-800-540-3765

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)