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

Purpose

Stool softener laxative

Description

Docusate sodium 250 mg


Medication Information

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
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

Description

Docusate sodium 250 mg

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

Do Not Use

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

Package Label
RITE AID Extra Strength Stool Softener Laxative
Questions Or Comments?

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

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
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

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

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
Questions Or Comments? (Questions or comments?)

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

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)