Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Starch, Corn Silicon Dioxide Sodium Benzoate Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: GPI;S1 Shape: round Color: white Size: 11 mm Score: 2

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-04-23

Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 100 mg

Uses

for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Directions

Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.

Children under 12 years of age: Consult a doctor before use.

Do Not Use

laxative products for longer than one week unless directed to do so by a doctor
if you are presently taking mineral oil unless told to do so by a doctor

Questions?

If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx

Other Information

Each tablet contains: Calcium 40 mg
Each tablet contains: Sodium 10 mg
Store at room temperature
Do not use if imprinted safety seal is broken or missing

Inactive Ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Principal Display Panel

healthy

mama

MOVE IT ALONG!

STOOL SOFTNER

Stop Use and Ask A Doctor If

you have rectal bleeding
you fail to have a bowel movement after use

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a doctor before use

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Docusate Sodium 100 mg

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses

for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.

Purpose

Stool Softener

Warnings

Directions

Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.

Children under 12 years of age: Consult a doctor before use.

Do Not Use (Do not use)

laxative products for longer than one week unless directed to do so by a doctor
if you are presently taking mineral oil unless told to do so by a doctor

Questions?

If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx

Other Information (Other information)

Each tablet contains: Calcium 40 mg
Each tablet contains: Sodium 10 mg
Store at room temperature
Do not use if imprinted safety seal is broken or missing

Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Principal Display Panel

healthy

mama

MOVE IT ALONG!

STOOL SOFTNER

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

These could be signs of a serious condition.

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

ask a doctor 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 right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 100 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 lasts over 2 weeks

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.", "Purpose": "Stool Softener", "Directions": "Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor. Children under 12 years of age: Consult a doctor before use.", "Do not use": "laxative products for longer than one week unless directed to do so by a doctor if you are presently taking mineral oil unless told to do so by a doctor", "Questions?": "If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx", "Other information": "Each tablet contains: Calcium 40 mg Each tablet contains: Sodium 10 mg Store at room temperature Do not use if imprinted safety seal is broken or missing", "Inactive ingredients": "Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.", "Principal Display Panel": "healthy mama MOVE IT ALONG! STOOL SOFTNER", "Stop use and ask a doctor if": "you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a doctor before use", "Keep out of Reach of Children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Docusate Sodium 100 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information