ft 455b

Drug Facts

Composition & Product

Active Ingredients

sennosides (8.6 mg) docusate (50 mg)

Inactive Ingredients

cellulose, microcrystalline croscarmellose sodium calcium phosphate, dibasic, anhydrous magnesium stearate polyethylene glycol, unspecified hypromelloses fd&c yellow no. 6 titanium dioxide talc silicon dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PSD22 Shape: round Color: orange Size: 9 mm Score: 1

Marketing Status

otc monograph drug active Since 2023-05-01

Medication Information

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

Ask a doctor before use if you have

stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts over two weeks

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.

Active Ingredient

Docusate Sodium 50 mg

Sennosides 8.6 mg

Uses

relieves occasional constipation (irregularity)

this product generally produces a bowel movement in 6 to 12 hours

Purpose

Stool softener

Laxative

Directions

• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor.

• If taking the maximum dosage, take in the morning and at bedtime.

Age	Starting Dose	Maximum Dose
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	2 tablets twice a day
children under 2 years	ask a doctor	ask a doctor

Other Information

each tablet contains: calcium 20 mg, sodium 3 mg
store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800-222-1222).

Package Label

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Structured Label Content

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

Ask a doctor before use if you have

stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts over two weeks

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.

Active Ingredient (Active ingredient (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg

Uses

relieves occasional constipation (irregularity)

this product generally produces a bowel movement in 6 to 12 hours

Purpose

Stool softener

Laxative

Directions

• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor.

• If taking the maximum dosage, take in the morning and at bedtime.

Age	Starting Dose	Maximum Dose
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	2 tablets twice a day
children under 2 years	ask a doctor	ask a doctor

Other Information (Other information)

each tablet contains: calcium 20 mg, sodium 3 mg
store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800-222-1222).

Package Label

Questions Or Comments? (Questions or Comments?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800-222-1222).", "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 Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts over two weeks 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.", "Directions": "• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor. • If taking the maximum dosage, take in the morning and at bedtime. Age Starting Dose Maximum Dose 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 2 tablets twice a day children under 2 years ask a doctor ask a doctor", "Other information": "each tablet contains: calcium 20 mg, sodium 3 mg store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).", "Inactive ingredients": "cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.", "Questions or Comments?": "Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "Active ingredient (in each tablet)": "Docusate Sodium 50 mg Sennosides 8.6 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information