Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 3593c39c-e8cb-4edb-a1d1-d49458652251
Route
ORAL
Published
Effective Date 2024-05-08
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 Sorbitan Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: P51;SCU1;D2 Shape: oval Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-01

Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take with a glass of water
adults and children 12 over and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
Product Label
RITE AID Stool Softener Laxative
Other Information
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in DulcoEase® Stool Softener

STOOL SOFTENER

DOCUSATE SODIUM, 100 mg

STOOL SOFTENER LAXATIVE

Comfortable relief of painful, hard, dry stools

Stimulant-free

Constipation relief

SOFTGELS

†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of DulcoEase®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

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



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

ask a health care 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 100 mg


Structured Label Content

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take with a glass of water
adults and children 12 over and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
Product Label
RITE AID Stool Softener Laxative
Other Information (Other information)
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in DulcoEase® Stool Softener

STOOL SOFTENER

DOCUSATE SODIUM, 100 mg

STOOL SOFTENER LAXATIVE

Comfortable relief of painful, hard, dry stools

Stimulant-free

Constipation relief

SOFTGELS

†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of DulcoEase®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

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



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 using a laxative. These could be a sign 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 care 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 100 mg


Advanced Ingredient Data


Raw Label Data

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