DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

Croscarmellose Sodium Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Fd&c Red No. 3 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Maltodextrin Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: none Shape: round Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-06-29

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 to 12 hours.

Section 50566-9

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.

Section 50569-3

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 2 weeks.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings:

Do not use: If you are now taking mineral oil, unless directed by a doctor. Laxative products for longer than 1 week, unless directed by a doctor.

Directions

Take preferably at bedtime or as directed by a doctor.

age	starting dosage	maximum dosage
adults & 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

Other Information

Each tablet contains: Calcium 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM
store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)

Inactive Ingredients

Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate,

Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.

Questions Or Comments?

Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

Principal Display Panel

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.

Active Ingredients (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Structured Label Content

Uses:

Relieves occasional constipation (irregularity).
Generally produces a bowel movement in 6 to 12 hours.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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 2 weeks.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Stool softener

Laxative

Warnings:

Do not use: If you are now taking mineral oil, unless directed by a doctor. Laxative products for longer than 1 week, unless directed by a doctor.

Directions (DIRECTIONS)

Take preferably at bedtime or as directed by a doctor.

age	starting dosage	maximum dosage
adults & 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

Other Information (OTHER INFORMATION)

Each tablet contains: Calcium 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM
store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate,

Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (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.

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

Docusate Sodium 50 mg

Sennosides 8.6 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses:": "Relieves occasional constipation (irregularity). Generally produces a bowel movement in 6 to 12 hours.", "50566-9": "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.", "50569-3": "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 2 weeks.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Stool softener Laxative", "Warnings:": "Do not use: If you are now taking mineral oil, unless directed by a doctor. Laxative products for longer than 1 week, unless directed by a doctor.", "DIRECTIONS": "Take preferably at bedtime or as directed by a doctor. age starting dosage maximum dosage adults & 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", "OTHER INFORMATION": "Each tablet contains: Calcium 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)", "INACTIVE INGREDIENTS": "Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.", "QUESTIONS OR COMMENTS?": "Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.", "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.", "Active Ingredients (in each tablet)": "Docusate Sodium 50 mg Sennosides 8.6 mg"}