OTC Medication Information: Stool Softener

STOOL SOFTENER- docusate sodium capsule, liquid filled
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using a laxative. These could be 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 (188-222-1222) right away

Directions

  • take with a glass of water
adults and children 12 years and over take 1 to 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 (77º); excursions permitted between 15-30ºC (59º-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

Questions or comments?

Call toll free 1-866-4-REXALL

Principal Display Panel

Stool Softener

Docusate Sodium 100 mg

Stool softener laxative

  • Stimulant-free

Softgels

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

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

Docusate Sodium USP, 100 mg
(click image for full-size original)

REXALL Stool Softener

STOOL SOFTENER
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-939(NDC:53345-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
CITRIC ACID MONOHYDRATE
Product Characteristics
Color red Score no score
Shape CAPSULE (Oval) Size 13mm
Flavor Imprint Code PC1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-939-20 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M007 12/15/2022
Labeler — Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 03/2024 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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