OTC Medication Information: Stool Softener Laxative

STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
Walgreens

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

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

Ask a doctor before use if you have

  • 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 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 (1-800-222-1222) right away.

Directions

  • take only by mouth. Doses may be taken as a single daily dose or in divided doses
adult and children 12 years and over take 1-3 softgels daily
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 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Colace® Regular Strength Stool Softener††

Stool Softener

DOCUSATE SODIUM 100 mg /

STOOL SOFTENER LAXATIVE

Regular Strength

  • Effective relief of occasional constipation
  • Gentle & dependable
  • Stimulant free

SOFTGELS

††This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc.,owner of the registered trademark Colace®.

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: WALGREEN CO.

DEERFIELD, IL 60015

Product Label

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

WALGREENS Regular Strength Stool Softener Laxative

STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4100
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
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
AMMONIA
ANHYDROUS CITRIC ACID
ALCOHOL
ISOPROPYL ALCOHOL
LECITHIN, SOYBEAN
MINERAL OIL
BUTYL ALCOHOL
POTASSIUM HYDROXIDE
Product Characteristics
Color red, white Score no score
Shape OVAL Size 12mm
Flavor Imprint Code PC18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-4100-60 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-4100-60)
2 NDC:0363-4100-40 400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC None
3 NDC:0363-4100-20 200 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 12/31/2020
Labeler — Walgreens (008965063)

Revised: 10/2023 Walgreens

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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