Drug Facts

Composition & Product

Active Ingredients

Docusate (250 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Anhydrous Citric Acid Isopropyl Alcohol Lecithin, Soybean Mannitol Mineral Oil Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: P4 Shape: capsule Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-10-14

Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 250 mg

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement within 12 to 72 hours

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use

if you are presently taking mineral oil, unless directed by a doctor.

Questions?

Call 1-877-753-3935Monday-Friday 9AM-5PM EST

Product Label

Other Information

each softgel contains:sodium 13 mg
store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink

Principal Display Panel

Extra Strength

Docusate Sodium

250 mg

Stool Softener Laxative

Softgels

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If Pregnant Or Breast Feeding

ask a health professional before use.

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 Ingredient (in Each Softgel)

Docusate sodium 250 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement within 12 to 72 hours

Purpose

Stool softener laxative

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed by a doctor.

Questions?

Call 1-877-753-3935Monday-Friday 9AM-5PM EST

Product Label

Other Information (Other information)

each softgel contains:sodium 13 mg
store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink

Principal Display Panel

Extra Strength

Docusate Sodium

250 mg

Stool Softener Laxative

Softgels

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

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

ask a health professional 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 (1-800-222-1222) right away.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 250 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 last over 2 weeks

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 within 12 to 72 hours", "Purpose": " Stool softener laxative", "Directions": "adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor", "Do not use": "if you are presently taking mineral oil, unless directed by a doctor.", "Questions?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Other information": "each softgel contains: sodium 13 mg store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)", "Inactive Ingredients": "anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink ", "Principal Display Panel": "Extra Strength Docusate Sodium 250 mg Stool Softener Laxative Softgels Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179", "Stop use and ask a doctor if": "you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week", "If pregnant or breast-feeding": "ask a health professional before use.", "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 ingredient (in each softgel)": " Docusate sodium 250 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information