FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
REMEDYREPACK INC.
Effective date
2021-04-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:47:44

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure16 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over take 1 - 3 softgels once daily or in divded doses children 2 to under 12 years of age 1 softgel once daily children under 2 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use if you are presently taking mineral oil, unless directed to do so by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - STOP USE SECTION

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 sings of a serious condition.

  • you need to use stool softner laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

Other informaiton

OTHER SAFETY INFORMATION

  • each softgel contains: s odium 7 mg
  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

HOW SUPPLIED SECTION

Docusate Sodium 100 mg Tablets, Red, Oval, Imprint: SCU1 supplied in:

NDC: 70518-2661-00

NDC: 70518-2661-01

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Docusate Sodium

GENERIC: Docusate Sodium

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-2661-0

NDC: 70518-2661-1

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 13 mm

IMPRINT: SCU1

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

  • WATER
  • SORBITOL
  • POLYETHYLENE GLYCOL 400
  • FD&C RED NO. 40
  • GLYCERIN
  • FD&C YELLOW NO. 6
  • GELATIN

MM1MM1

MM2MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2661-02023-10-16C16284748780-1f386c649-e1da-0266-e053-dadaa90a7c1aDocusate Sodium 100 mg
70518-2661-12023-10-16C16284748780-1f386c649-e1da-0266-e053-dadaa90a7c1aDocusate Sodium 100 mg
70518-2661-02023-01-30C16284748780-1f386c649-e1da-0266-e053-dadaa90a7c1aDocusate Sodium 100 mg
70518-2661-12023-01-30C16284748780-1f386c649-e1da-0266-e053-dadaa90a7c1aDocusate Sodium 100 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-044-01EA - Each69618-0445b004dec-1b24-4e29-89ef-d73df6f2479412017-12-14
69618-044-10EA - Each69618-044f28ec5a7-79ec-485d-b308-0d36c8d3e13c12017-12-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-266170518-2661-0, 70518-2661-1
69618-044

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

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
f6c88d87-66a6-2962-e053-6294a90acfbe224a671e-2c97-46fb-81d8-3c2fafe2aaa52023-03-13WarningsExact identifier
spl set id: 224a671e-2c97-46fb-81d8-3c2fafe2aaa5

Reported adverse events (FAERS/openFDA)#

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