Drug Mart Vegetable Laxative Plus Stool Softener Tablet
FDA Label NDC 53943-153

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart, Inc for the product Drug Mart Vegetable Laxative Plus Stool Softener (NDC 53943-153). 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 tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, 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 Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

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

Warnings

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

    • 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 or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

      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 preferably at bedtime or as directed by a doctor
    • AgeStarting DosageMaximum Dosage
    adults and children

    12 years and over

    		2 tablets once a day4 tablets twice a day
    children 6 to

    under 12 years

    		1 tablet once a day2 tablets twice a day
    children 2 to

    under 6 years

    		½ tablet once a day1 tablet twice a day
    children under

    2 years

    		ask a doctorask a doctor

Other Information

  • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
  • store between 20-25°C (68-77°F)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

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