FDA.reportPublic FDA data

Stool Softener

Manufacturer
CVS Pharmacy
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:10:00

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE CALCIUM
Label structure10 sections

Indications and uses

for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate calcium 240 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, purified water, sorbitol special

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Surfak®† 

Stool Softener

DOCUSATE CALCIUM, 240 mg

Stool Softener Laxative

Sodium Free

  • Gentle Relief of Constipation
  • Once-a-day dosage

SOFTGELS

†This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS HEALTH Stool Softener Laxative
CVS HEALTH Stool Softener Laxative

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-134-012020-10-21C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-102020-10-21C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-012020-09-27C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-102020-09-27C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-012020-09-25C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-102020-09-25C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-012020-07-22C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts
59779-134-102020-07-22C16284748780-1ab0e2407-338e-f274-e053-dbdaa90a6471Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-134-01EA - Each59779-134d6ea1f76-6780-4b58-a9d2-c7f45b3d535a12019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE CALCIUMACTIVE INGREDIENT6K7YS503HC2
DOCUSATEACTIVE MOIETYM7P27195AG2
CORN OILINACTIVE INGREDIENT8470G57WFM2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
GELATININACTIVE INGREDIENT2G86QN327L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
SORBITANINACTIVE INGREDIENT6O92ICV9RU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-13459779-134-01, 59779-134-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE CALCIUM6K7YS503HCACTIB
CORN OIL8470G57WFMIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 290 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, FILM COATED / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSYRUP / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8FILM / SUBLINGUAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCONCENTRATE / ORAL0.02 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, COATED / ORAL3.17 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a19d14f2-547d-47be-a2bf-772fe6541c5e1d3577be-93f7-4a7d-866f-e3578e93fefd2024-03-06WarningsExact identifier
spl id: a19d14f2-547d-47be-a2bf-772fe6541c5e
spl set id: 1d3577be-93f7-4a7d-866f-e3578e93fefd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.