Gentle Stool Softener

Gentle Stool Softener
SPL v5
SPL
SPL Set ID 169b33f9-e559-47bf-bbba-c7eda4762c7f
Route
ORAL
Published
Effective Date 2023-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Water Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: SD23 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-21

Description

Drug Facts

Purpose

Stool Softner laxative


Medication Information

Warnings and Precautions

Warnings

Do not use if you are presently taking mineral o il

Purpose

Stool Softner laxative

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222 righ away.

Section 53414-9

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

uses
  • relieves of occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours
Directions
  • take with a glass of water

Adults and children 12 years of age and over

take 1 to 3 capsules daily. This dose may be taken as asingle daily dose or ib divided doses.

Children 2 to under 12 years of age

1 capsule daily.

Children under 2 years of age

Ask a doctor

Other Information
  • each capsule contains: sodium 5 mg Very Low Sodium
  • Store at room temperature 20-25°C (68-77°F)
  • protect from excessive humidity
Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol solution.

Questions Or Comments?

1-800-373-6981

Principal Display Panel

Compare to Dulcolax ® Stool Softener active ingredient *

GENTLE STOOL SOFTENER

DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

25 LIQUID GELS

stop Use and Ask A Doctor If You
  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo need to use laxative for more than 1 week
ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomittiong
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Active Ingredient (in Each Liquid Filled Capsule)

Docusate Sodium 100 mg 


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Do not use if you are presently taking mineral o il

Section 42229-5 (42229-5)

Drug Facts

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.1(800)222-1222 righ away.

Section 53414-9 (53414-9)

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

Purpose

Stool Softner laxative

uses (Uses)
  • relieves of occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours
Directions
  • take with a glass of water

Adults and children 12 years of age and over

take 1 to 3 capsules daily. This dose may be taken as asingle daily dose or ib divided doses.

Children 2 to under 12 years of age

1 capsule daily.

Children under 2 years of age

Ask a doctor

Other Information (Other information)
  • each capsule contains: sodium 5 mg Very Low Sodium
  • Store at room temperature 20-25°C (68-77°F)
  • protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol solution.

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Dulcolax ® Stool Softener active ingredient *

GENTLE STOOL SOFTENER

DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

25 LIQUID GELS

stop Use and Ask A Doctor If You (Stop use and ask a doctor if you)
  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo need to use laxative for more than 1 week
ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain, nausea or vomittiong
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Docusate Sodium 100 mg 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)