Docuzen Tablet
FDA Label NDC 71574-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Village Pharma for the product Docuzen (NDC 71574-700). 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 active ingredients (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

Laxative

Stool Softner

Uses

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

Warnings

Do not use

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

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

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

    • These may indicate a serious condition.

If Pregnant Or Breast Feeding,

ask a healthcare professional before use. 

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • take preferably at bedtime or as directed by a doctor

    • age

    starting dosage

    maximum dosage

    Adults and children 12 years and over

    2 tablets once a day 

    4 tablets twice a day

    Children 6 to under 12 years

    1 tablet once a day

    2 tablets  twice a day

    Children 2 to under 6 years 

    1/2 tablet  once a day

    1 tablet twice a day

    Children under 2 years

    ask a doctor

    ask a  doctor

Other Information

  • each tablet contains 10 mg of calcium, sodium 5 mg
  • store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF)

Inactive Ingredients

croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc & titanium dioxide.

Questions Or Comments?

1-800-828-0464 Mon-Fri 8 AM to 4 PM

Package Label.Principal Display Panel

VillagePharma

NDC 71574-700-60

DOCUZEN

Sennosides 8.6mg &

Docusate Sodium 50mg

60 TABLETS

Manufactured in the USA

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