phillips ®

phillips ®
SPL v14
SPL
SPL Set ID b0462555-5554-4a17-a1fe-4206a4fd350d
Route
oral
Published
Effective Date 2016-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Stool softener laxative

Description

Drug Facts


Medication Information

Warnings

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

Purpose

Stool softener laxative

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

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.

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

Warnings

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

Purpose

Stool softener laxative

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

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.

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


Raw Label Data

All Sections (JSON)