drug facts

drug facts
SPL v4
SPL
SPL Set ID 056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138
Route
oral
Published
Effective Date 2024-03-15
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 polyethylene glycol, unspecified propylene glycol water sorbitol glycerin citric acid monohydrate sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-12-30

Purpose

Stool softener laxative

Description

Docusate Sodium USP, 100 mg


Medication Information

Uses
  • for 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 years 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
Other Information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



Inactive Ingredients

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink



Description

Docusate Sodium USP, 100 mg

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener*

Stool Softener

DOCUSATE SODIUM 100 mg

Stool Softener Laxative

  • Relief of occasional constipation
  • Works gradually
  • Safe to take

Gentle, softening relief

SOFTGELS

*This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® 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



Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor.

Product Label
CVS HEALTH Stool Softener Laxative
Questions Or Comments?

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

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 stool softener 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 (1-800-2222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate Sodium USP, 100 mg


Structured Label Content

Uses
  • for 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 years 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
Other Information (Other information)
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)



Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink



Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener*

Stool Softener

DOCUSATE SODIUM 100 mg

Stool Softener Laxative

  • Relief of occasional constipation
  • Works gradually
  • Safe to take

Gentle, softening relief

SOFTGELS

*This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® 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



Do Not Use (Do not use)

if you are presently taking mineral oil, unless told to do so by a doctor.

Product Label
CVS HEALTH Stool Softener Laxative
Questions Or Comments? (Questions or comments?)

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

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 stool softener 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 (1-800-2222-1222) right away.

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

Docusate Sodium USP, 100 mg


Advanced Ingredient Data


Raw Label Data

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