drug facts

drug facts
SPL v3
SPL
SPL Set ID 88cc2575-27a1-4514-bc41-bd1eac283814
Route
oral
Published
Effective Date 2024-06-13
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 Dulcolax® Stool Softener active ingredient†

stool softener

docusate sodium 100 mg

stool softener laxative

  • comfortable relief of painful, hard, dry stools
  • stimulant-free
  • Relief of occasional constipation

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 UNFI

PROVIDENCE, RI 02908 USA

Do Not Use

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

Product Label
EQUALINE Stool Softener Laxative
Questions Or Comments?

 Call toll free 1-855-423-2630

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 Dulcolax® Stool Softener active ingredient†

stool softener

docusate sodium 100 mg

stool softener laxative

  • comfortable relief of painful, hard, dry stools
  • stimulant-free
  • Relief of occasional constipation

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 UNFI

PROVIDENCE, RI 02908 USA

Do Not Use (Do not use)

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

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

 Call toll free 1-855-423-2630

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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