Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 541a3c87-8e78-443d-aa49-7663ae72b744
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Mannitol Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: P20 Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-29

Description

Docusate sodium 250 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 250 mg

Uses
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours
Directions
  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor
Do Not Use

if you are presently taking mineral oil, unless directed by a doctor.

Package Label
RITE AID Extra Strength Stool Softener Laxative
Other Information
  • each softgel contains: sodium 15 mg
  • store at 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

STOOL SOFTENER LAXATIVE

COL• RITE

DOCUSATE SODIUM 250 mg

Stimulant free

Relief of occasional constipation

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Softgel)

Docusate sodium 250 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed by a doctor.

Package Label
RITE AID Extra Strength Stool Softener Laxative
Other Information (Other information)
  • each softgel contains: sodium 15 mg
  • store at 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

STOOL SOFTENER LAXATIVE

COL• RITE

DOCUSATE SODIUM 250 mg

Stimulant free

Relief of occasional constipation

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Docusate sodium 250 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)