FDA.reportPublic FDA data

Colon Detox

Manufacturer
OPMX LLC
Effective date
2026-11-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-11-07 03:01:52

Label at a glance#

ProductColon Detox
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure8 sections

Indications and uses

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours.

Dosage and administration

take preferably at bedtime or as directed by a doctor age starting dose maximum dose adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Storage and handling

each tablet contains: calcium 21 mg each tablet contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Docusate sodium 50 mgStool softner
Sennosides 8.6 mgLaxative

Uses

INDICATIONS & USAGE SECTION

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless directed by a doctor.
  • laxative products should not be used for a period longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomitting
  • 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 failure to have a bowel movement after use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding

PREGNANCY 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

take preferably at bedtime or as directed by a doctor

agestarting dosemaximum dose
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 3 mg VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 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

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow #10, FD&C Yellow #6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

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

Colon Detox

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colon Detox

Colon Cleanser

Helps Lose Belly Fat

Stool Softener

60 Tablets

CDCD

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181355GTIN-13: 0810053181355
EAN-13: 0810053181355
GTIN-12: 810053181355
UPC-A: 810053181355
GTIN storage (14 digits): 00810053181355		COLON DETOX.jpg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-15169729-151-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-02-21full-release2026-06-01 00:08:54

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
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
ndc (package): 69729-151-60
ndc (product): 69729-151
ndc11 (package): 69729015160
spl set id: 0a4d3265-080c-d2ed-e063-6394a90adbee

Reported adverse events (FAERS/openFDA)#

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