FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
REMEDYREPACK INC.
Effective date
2021-09-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:36:08

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults 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

Storage and handling

each softgel contains: sodium 6 mg very low sodium store at 20-25°C (68-77°F)

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

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless told to do so 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

do not exceed the maximum recommended daily dosage in a 24-hour period

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults 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

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 6 mg
  • very low sodium
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

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, LIQUID FILLED

ADMINSTRATION: ORAL

NDC: 70518-3167-0

NDC: 70518-3167-1

NDC: 70518-3167-2

NDC: 70518-3167-3

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 13 mm

IMPRINT: L486

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

  • D&C RED NO. 33
  • FD&C BLUE NO. 1
  • FD&C RED NO. 40
  • FD&C YELLOW NO. 6
  • GELATIN
  • GLYCERIN
  • POLYETHYLENE GLYCOL
  • WATER
  • SORBITAN
  • SORBITOL
  • TITANIUM DIOXIDE

Remedy_LabelRemedy_Label

MM2MM2

MM3MM3

MM4MM4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3167-02025-09-11C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts
70518-3167-22025-09-11C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts
70518-3167-32025-09-11C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts
70518-3167-02023-01-30C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts
70518-3167-22023-01-30C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts
70518-3167-32023-01-30C16284748780-1f386c64a-0b01-0266-e053-dadaa90a7c1aPerrigo Docusate Sodium 100 mg Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3167DOCUSATE SODIUM CAPSULE, LIQUID FILLED [REMEDYREPACK INC.]3Legacy NDC20210916_9803cd5b-6e36-43eb-be9a-ad72cf645981.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-486-78EA - Each45802-486efff330d-ac0a-4908-8da3-b9e544bfb32412012-07-24

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
70518-316770518-3167-1, 70518-3167-0, 70518-3167-2, 70518-3167-3
45802-486

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
22f42296-912d-098c-e063-6394a90a1c109803cd5b-6e36-43eb-be9a-ad72cf6459812024-09-25WarningsExact identifier
spl set id: 9803cd5b-6e36-43eb-be9a-ad72cf645981
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
ndc (product): 45802-486

Reported adverse events (FAERS/openFDA)#

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