Phillips ®

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Propylene Glycol Water Shellac Sodium Hydroxide Titanium Dioxide Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: P10 Shape: oval Color: red Size: 4 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-09-02 Until 2023-12-01

Medication Information

Purpose

Stool softener laxative

Description

Drug Facts

Use

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9

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

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

take softgels with a full glass (8 oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other Information

each softgel contains: sodium 6 mg
very low sodium
store at room temperature. Avoid excessive heat 40°C (104°F).

Inactive Ingredients

FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Principal Display Panel 30 Capsule Carton

Structured Label Content

Use

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Section 42229-5 (42229-5)

Drug Facts

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9 (53414-9)

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

Purpose

Stool softener laxative

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

take softgels with a full glass (8 oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other Information (Other information)

each softgel contains: sodium 6 mg
very low sodium
store at room temperature. Avoid excessive heat 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com

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

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

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

Docusate sodium 100 mg

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

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Principal Display Panel 30 Capsule Carton (PRINCIPAL DISPLAY PANEL - 30 Capsule Carton)

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 12 to 72 hours", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking mineral oil", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Stool softener laxative", "Warnings": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "Directions": "take softgels with a full glass (8 oz) of water adults and children 12 years and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor", "Other information": "each softgel contains: sodium 6 mg very low sodium store at room temperature. Avoid excessive heat 40°C (104°F).", "Inactive ingredients": "FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide", "Questions or comments?": "1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com", "Stop use and ask a doctor if": "you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week", "Active ingredient (in each softgel)": "Docusate sodium 100 mg", "Ask a doctor before use if you have": "stomach pain, nausea, or vomiting a sudden change in bowel habits that lasts over 14 days"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information