Senna-s

Senna-s
SPL v4
SPL
SPL Set ID f36c509e-b93b-4d7f-a18a-41e585369a15
Route
ORAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Microcrystalline Cellulose 200 Starch, Corn Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol Titanium Dioxide Polyethylene Glycol 3350 Talc Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 5 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: G187 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-29

Description

Docusate Sodium         50 mg Sennosides                       8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium         50 mg Sennosides                       8.6 mg

Uses
  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours
Warnings

Directions
  • Take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children

12 years of age and over
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

Do Not Use
  • If you are now taking mineral oil, unless directed by a doctor
  • Laxative products for longer than one week unless directed by a doctor
Drug Facts

Other Information
  • Each tablet contains: Calcium 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake

Principal Display Panel

NDC 63561-0187-01

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

100 Film-Coated Tablets

NDC 63561-0187-02

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

NDC 63561-0187-03

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

1000 Film-Coated Tablets

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 (1-800-222-1222) right away.

Stop Using 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.

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 continues over a period of two weeks

Structured Label Content

Uses
  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours
Purpose

Stool softener

Laxative

Warnings

Directions
  • Take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children

12 years of age and over
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

Do Not Use (Do not use)
  • If you are now taking mineral oil, unless directed by a doctor
  • Laxative products for longer than one week unless directed by a doctor
Drug Facts

Other Information (Other information)
  • Each tablet contains: Calcium 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake

Principal Display Panel

NDC 63561-0187-01

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

100 Film-Coated Tablets

NDC 63561-0187-02

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

NDC 63561-0187-03

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

1000 Film-Coated Tablets

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 (1-800-222-1222) right away.

Stop Using and Ask A Doctor If (Stop using 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.

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 continues over a period of two weeks

Advanced Ingredient Data


Raw Label Data

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