Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 849b057a-dc46-423c-a2f4-b01f135a3803
Route
ORAL
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P10;SCU2;D1 Shape: oval Color: red Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-31

Description

Docusate sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take softgels with a full glass (8 oz) of water
adults and children 12 years and older take 1-3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses 
children 6 to under 12 years of age  take 1 softgel daily or as directed by a doctor 
children under 6 years of age  ask a doctor 


Product Label
CVS HEALTH Stool Softener Laxative
Other Information
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*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 Phillips'® Stool Softener**

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Relieves constipation

Gentle, dependable relief

Stimulant-free

Cramp-free

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® Stool Softener.

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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com®

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 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over 14 days
Ask A Doctor Or Pharmacist Before Use If You Are

presently taking mineral oil.


Structured Label Content

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

Stool softener laxative

Directions
  • take softgels with a full glass (8 oz) of water
adults and children 12 years and older take 1-3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses 
children 6 to under 12 years of age  take 1 softgel daily or as directed by a doctor 
children under 6 years of age  ask a doctor 


Product Label
CVS HEALTH Stool Softener Laxative
Other Information (Other information)
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*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 Phillips'® Stool Softener**

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Relieves constipation

Gentle, dependable relief

Stimulant-free

Cramp-free

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® Stool Softener.

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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com®

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 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over 14 days
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or Pharmacist before use if you are)

presently taking mineral oil.


Advanced Ingredient Data


Raw Label Data

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