Dual Action Senna Stool Softener Capsule, Liquid Filled
FDA Label NDC 83059-0091

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Dual Action Senna Stool Softener (NDC 83059-0091). 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 drug facts, active ingredients (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - stop use, 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

Drug Facts

Active Ingredients (In Each Softgel)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

Otc - Do Not Use

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week, unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Stop Use

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 

    • These may indicate a serious condition.

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 (1-800-222-1222) right away.

Directions

  • take preferably at bedtime or as directed by a doctor
    • Age

    Arting Dosage

    		Maximum Dosage
    adults and children 12 years of age and older2 softgels once a day4 softgels twice a day
    children 6 to under 12 years1 softgel once a day2 softgels twice a day
    children under 6 years of ageask a doctorask a doctor

Other Information

  • each softgel contains:sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol 400, povidone (PVP K-30), propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide, yellow beeswax

Questions Or Comments?

1-800-373-6981 (toll-free)

Other

Distributed by:
nexmed
Holbrook, NY 11741

Package Label & Principal Display

dual-action
senna+
stool softener

Label

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