Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg)

Inactive Ingredients

D&c Red No. 33 Methylparaben Polyethylene Glycol 400 Propylene Glycol Propylparaben Sodium Benzoate Sodium Citrate, Unspecified Form Water Poloxamer 181

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Completed Since 1997-08-01 Until 2023-11-17

Medication Information

Purpose

Stool Softener Laxative

Description

Docusate Sodium 50 mg

Uses

relieves occasional constipation
generally produces bowel movement in 12-72

Directions

may be taken once daily or in divided doses
give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12	1 to 7 teaspoons
children 2 to under 12	1 to 3 teaspoons
children under 2	ask a doctor

Do Not Use

if you are presently taking mineral oil
when abdominal pain, nausea, or vomiting are present
for longer than one week

Active Ingredient

Docusate Sodium 50 mg

Other Information

each teaspoon contains:sodium 5 mg
shake well before using
store at controlled room temperature 15° - 30°C (59° - 86°F)
dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
store in an upright position

Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions Or Comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

Stop Use and Ask A Doctor If

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that lasts over two weeks.

Package/label Principal Display Panel

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Structured Label Content

Uses

relieves occasional constipation
generally produces bowel movement in 12-72

Purpose

Stool Softener Laxative

Directions

may be taken once daily or in divided doses
give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12	1 to 7 teaspoons
children 2 to under 12	1 to 3 teaspoons
children under 2	ask a doctor

Do Not Use

if you are presently taking mineral oil
when abdominal pain, nausea, or vomiting are present
for longer than one week

Active Ingredient (Active ingredient)

Docusate Sodium 50 mg

Other Information (Other information)

each teaspoon contains:sodium 5 mg
shake well before using
store at controlled room temperature 15° - 30°C (59° - 86°F)
dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
store in an upright position

Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions Or Comments? (Questions or comments?)

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

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

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate a serious condition.

Keep Out of Reach of Children

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

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

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

noticed a sudden change in bowel habits that lasts over two weeks.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Advanced Ingredient Data

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 181", "unii": "09Y8E6164A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation generally produces bowel movement in 12-72", "Purpose": "Stool Softener Laxative", "Directions": "may be taken once daily or in divided doses give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation adults and children over 12 1 to 7 teaspoons children 2 to under 12 1 to 3 teaspoons children under 2 ask a doctor", "Do Not Use": "if you are presently taking mineral oil when abdominal pain, nausea, or vomiting are present for longer than one week", "Active ingredient": "Docusate Sodium 50 mg", "Other information": "each teaspoon contains: sodium 5 mg shake well before using store at controlled room temperature 15° - 30°C (59° - 86°F) dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP store in an upright position", "Inactive Ingredients": "D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.", "Questions or comments?": "DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. 20101 N.E 16TH PLACE MIAMI, FL 33179 ", "Stop use and ask a doctor if": "you have rectal bleeding you fail to have a bowel movement after use of this product These may indicate a serious condition.", "Keep Out of Reach of Children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Ask a doctor before use if you have": "noticed a sudden change in bowel habits that lasts over two weeks.", "Ask a doctor or pharmacist before use if you are": "taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information