FDA.reportPublic FDA data

Gentle Relief Stool Softner

Manufacturer
Healthlife of USA | Softech Pharma Pvt. Ltd.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:23:47

Label at a glance#

ProductGentle Relief Stool Softner
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

For prevention of dry, hard stools For relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

Take with a glass of water Adults and children 12 years of age and over: Take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses Children 2 to under 12 years of age: Take 1 softgel daily Children under 2 years of age: Consult a physician

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Gentle Relief Stool Softner

Purpose

OTC - PURPOSE SECTION

Stool Softner

Active Ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100mg

Uses

INDICATIONS & USAGE SECTION

  • For prevention of dry, hard stools
  • For relief of occasional constipation.

This product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

  • If you are presently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • For longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You have rectal bleeding 
  • you fail to have a bowel movement after use

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

Overdose warning: In case of overdosage, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take with a glass of water
  • Adults and children 12 years of age and over: Take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses
  • Children 2 to under 12 years of age: Take 1 softgel daily
  • Children under 2 years of age: Consult a physician

Other Information

OTC - QUESTIONS SECTION

Each softgel contains sodium 6 mg
Store at controlled room temperature 15°-30°C (59°-86°F)
Read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • FD&C Red # 40
  • FD&C Yellow # 6
  • Gelatin
  • Glycerin
  • Polyethylene glycol 400
  • Propylene glycol
  • Purified water
  • Sorbitol solution
  • Titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Gentle Relief Stool Softner Docusate Sodium 100mg Gentle and Easy Relief of Constipation 24 Softgels Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Dulcolax® Stool Softner active ingredients

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-124GENTLE RELIEF STOOL SOFTNER (GENTLE RELIEF STOOL SOFTNET) CAPSULE, GELATIN COATED [HEALTHLIFE OF USA]11Legacy NDC20231021_d1104eb0-70cd-4c27-bf05-6d09c3a731c0.zip

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
69517-12469517-124-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML · Source PDF

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
404e4bfa-2ef8-3b90-e063-6394a90a5782d1104eb0-70cd-4c27-bf05-6d09c3a731c02025-10-04WarningsExact identifier
spl set id: d1104eb0-70cd-4c27-bf05-6d09c3a731c0

Reported adverse events (FAERS/openFDA)#

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