Phillips Stool Softener Capsule, Liquid Filled
FDA Label NDC 0280-1012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Phillips Stool Softener (NDC 0280-1012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, use, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Use

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

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

  • take softgels with a full glass (8 oz) of water
    • adults and children 12 years and oldertake 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 yearstake 1 softgel daily or as directed by a doctor
    children under 6 years of ageask 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

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