Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 16daaa1e-19c3-414c-91c2-624ac573b960
Route
ORAL
Published
Effective Date 2025-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Talc Titanium Dioxide Silicon Dioxide Aluminum Oxide Fd&c Blue No. 2 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-06-30 Until 2026-06-30

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative


Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Directions
  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years and over  take 2-4 tablets daily
 children 6 to under 12 years of age  take 1-2 tablets daily
 children 2 to under 6 years of age  take up to 1 tablet daily
 children under 2  ask a doctor




Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
  • if you are now taking mineral oil, unless directed by a doctor
Product Label
GOOD SENSE Stool Softener
Other Information
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF), excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&c blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Overnight Relief

Stimulant Laxative Plus

Stool Softener

Docusate sodium 50 mg

Sennosides 8.6 mg

†Compare to active ingredients in Colace® 2-IN-1

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

Distributed by: Geiss, Destin & Dunn, Inc.,

Peachtree City, GA 30269

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredients (in Each Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Purpose

Stool softener

Stimulant laxative

Directions
  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years and over  take 2-4 tablets daily
 children 6 to under 12 years of age  take 1-2 tablets daily
 children 2 to under 6 years of age  take up to 1 tablet daily
 children under 2  ask a doctor




Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
  • if you are now taking mineral oil, unless directed by a doctor
Product Label
GOOD SENSE Stool Softener
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF), excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&c blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Overnight Relief

Stimulant Laxative Plus

Stool Softener

Docusate sodium 50 mg

Sennosides 8.6 mg

†Compare to active ingredients in Colace® 2-IN-1

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

Distributed by: Geiss, Destin & Dunn, Inc.,

Peachtree City, GA 30269

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Docusate sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

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