Safecor Health

Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg)

Inactive Ingredients

Fd&c Red No. 40 Methylparaben Poloxamer 124 Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Benzoate Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-01

Medication Information

Purpose

Stool Softener

Dosage and Administration

Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
Adults and children 12 years of age and over	5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor
Children 6 to 12 years of age	4 mL to 15 mL (3 teaspoons) or as directed by a doctor
Children 3 to 6 years of age	2 mL to 6 mL or as directed by a doctor
Children under 3 years of age	1 mL to 4 mL or as directed by a doctor

1 teaspoon = 5 mL

Description

Docusate Sodium 50 mg

Use:

Relief of occasional constipation

Section 50565-1

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

Section 50566-9

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days.

These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

Section 50569-3

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

Section 50570-1

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

Section 51727-6

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified

water, sodium benzoate, sodium citrate, and sucralose.

NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473

3 4843322010 8

Section 53414-9

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

Section 60561-8

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions

between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

Principal Display Panel Box Label

SAFECOR

HEALTH

Docusate Sodium Liquid

100 mg / 10 ml

Contains 40 (10 ml) Unit Dose Cups

See monograph for complete drug information.

NDC: 48433-220-40

QTY: 40

Lot: 21A0079

Exp: 2023-03-31

Store at room temperature 20°C-25°C (68°F-77°F);

excursions between 15°C-30°C (59°F-86°F) are allowed.

Protect from excessive heat. Protect from light.

This package design is not child resistant. For institutional use only.

Shake well before use.

3 48433 22040 5

Pkg By: Safecor Health, LLC Columbus, OH 43204

Questions or Comments: Call 1-800-447-1006

GTIN: 00348433220405

SN: 212802331

Exp; 2023-03-31

Lot 21A0079 PN5689.C

Principal Display Panel Lid Label

Delivers 1 0 mL

NDC 48433-220-10

Docusate

Sodium Liquid

100 mg/10mL

SHAKE WELL

348433220108

Pkg By: Safecor Health, LLC

Columbus, OH 43204

PN5618.B

Active Ingredient (in Each 5 Ml = 1 Teaspoonful)

Docusate Sodium 50 mg

Structured Label Content

Use:

Relief of occasional constipation

Dosage and Administration (34068-7)

Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
Adults and children 12 years of age and over	5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor
Children 6 to 12 years of age	4 mL to 15 mL (3 teaspoons) or as directed by a doctor
Children 3 to 6 years of age	2 mL to 6 mL or as directed by a doctor
Children under 3 years of age	1 mL to 4 mL or as directed by a doctor

1 teaspoon = 5 mL

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days.

These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

Section 50569-3 (50569-3)

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

Section 50570-1 (50570-1)

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified

water, sodium benzoate, sodium citrate, and sucralose.

NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473

3 4843322010 8

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions

between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

Purpose

Stool Softener

Principal Display Panel Box Label (Principal Display Panel - Box Label)

SAFECOR

HEALTH

Docusate Sodium Liquid

100 mg / 10 ml

Contains 40 (10 ml) Unit Dose Cups

See monograph for complete drug information.

NDC: 48433-220-40

QTY: 40

Lot: 21A0079

Exp: 2023-03-31

Store at room temperature 20°C-25°C (68°F-77°F);

excursions between 15°C-30°C (59°F-86°F) are allowed.

Protect from excessive heat. Protect from light.

This package design is not child resistant. For institutional use only.

Shake well before use.

3 48433 22040 5

Pkg By: Safecor Health, LLC Columbus, OH 43204

Questions or Comments: Call 1-800-447-1006

GTIN: 00348433220405

SN: 212802331

Exp; 2023-03-31

Lot 21A0079 PN5689.C

Principal Display Panel Lid Label (Principal Display Panel - Lid Label)

Delivers 1 0 mL

NDC 48433-220-10

Docusate

Sodium Liquid

100 mg/10mL

SHAKE WELL

348433220108

Pkg By: Safecor Health, LLC

Columbus, OH 43204

PN5618.B

Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active Ingredient (in each 5 mL = 1 teaspoonful))

Docusate Sodium 50 mg

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 124", "unii": "1S66E28KXA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use:": "Relief of occasional constipation", "34068-7": "Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response Adults and children 12 years of age and over 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor Children 6 to 12 years of age 4 mL to 15 mL (3 teaspoons) or as directed by a doctor Children 3 to 6 years of age 2 mL to 6 mL or as directed by a doctor Children under 3 years of age 1 mL to 4 mL or as directed by a doctor 1 teaspoon = 5 mL", "50565-1": "Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.", "50566-9": "Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation", "50569-3": "Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil", "50570-1": "Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor", "51727-6": "Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8", "53414-9": "If pregnant or breast feeding , ask a health care professional before use.", "60561-8": "Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.", "Purpose": "Stool Softener", "Principal Display Panel - Box Label": "SAFECOR HEALTH Docusate Sodium Liquid 100 mg / 10 ml Contains 40 (10 ml) Unit Dose Cups See monograph for complete drug information. NDC: 48433-220-40 QTY: 40 Lot: 21A0079 Exp: 2023-03-31 Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. This package design is not child resistant. For institutional use only. Shake well before use. 3 48433 22040 5 Pkg By: Safecor Health, LLC Columbus, OH 43204 Questions or Comments: Call 1-800-447-1006 GTIN: 00348433220405 SN: 212802331 Exp; 2023-03-31 Lot 21A0079 PN5689.C", "Principal Display Panel - Lid Label": "Delivers 1 0 mL NDC 48433-220-10 Docusate Sodium Liquid 100 mg/10mL SHAKE WELL 348433220108 Pkg By: Safecor Health, LLC Columbus, OH 43204 PN5618.B", "Active Ingredient (in each 5 mL = 1 teaspoonful)": "Docusate Sodium 50 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information