FDA.reportPublic FDA data

Rite Aid Stool Softener

Manufacturer
Rite Aid | Reese Pharmaceutical Co | Swiss Caps Romania
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:29

Label at a glance#

ProductRite Aid Stool Softener
Active ingredientDOCUSATE CALCIUM
Label structure12 sections

Indications and uses

For the relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Dosage and administration

Adults and Children over 12 years of age Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Calcium 240 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • For the relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to 72 hours.

Warnings: Do not use

WARNINGS SECTION

  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For longer than one week unless directed by a doctor.

Ask a Doctor Before Use

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.
  • You fail to have a bowel movement after use.

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare professional before use.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
  • Do not use if either seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245376docusate calcium 240 MG Oral CapsulePSN4
1245376docusate calcium 240 MG Oral CapsuleSCD4
1245376DOSS Calcium 240 MG Oral CapsuleSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7810-0Rite Aid Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7810RITE AID STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RITE AID]4Current NDC, Legacy NDC, 1 package rows20241220_281b2bc7-4980-4205-a33f-cb1974af8d06.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-781011822-7810-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
DOCUSATE CALCIUM6K7YS503HCACTIB

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
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
ndc (package): 11822-7810-0
ndc (product): 11822-7810
ndc11 (package): 11822781000
spl id: e177e6ad-be83-4327-963f-e93dca006c25
spl set id: 281b2bc7-4980-4205-a33f-cb1974af8d06

Reported adverse events (FAERS/openFDA)#

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