drug facts

drug facts
SPL v5
SPL
SPL Set ID abac28e1-ad2f-4b92-975b-9d8a18d43665
Route
oral
Published
Effective Date 2024-09-09
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 fd&c red no. 40 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified silicon dioxide talc titanium dioxide aluminum oxide fd&c blue no. 2

Identifiers & Packaging

Pill Appearance
Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-10-01

Purpose

Stool softener Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 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 older 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 


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

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Principal Display Panel

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

Stool Softener

+ Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

For overnight relief of occasional constipation

Tablets

This product is not manufactured or distributed by Avrio Health L.P., distributor of Peri-Colace®.

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

Distributed by McKesson Corp.

6555 State Highway 161 Irving, TX 75039

healthmart.com

Do Not Use
  • laxative products for longer than 1 week unless directed  by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor
Product Label
HEALTH MART Stool Softener
Questions Or Comments?

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

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of 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 to12 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 older 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 


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

Principal Display Panel

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

Stool Softener

+ Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

For overnight relief of occasional constipation

Tablets

This product is not manufactured or distributed by Avrio Health L.P., distributor of Peri-Colace®.

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

Distributed by McKesson Corp.

6555 State Highway 161 Irving, TX 75039

healthmart.com

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed  by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor
Product Label
HEALTH MART Stool Softener
Questions Or Comments? (Questions or comments?)

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

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 could be signs of 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

All Sections (JSON)