Vegetable Laxative
FDA Label NDC 68210-5017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Vegetable Laxative (NDC 68210-5017). 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 ingredient (in each tablet), puropse, uses, warnings, do not use, ask a doctor before use if you have, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Sennosides 8.6 mg

Puropse

Laxative

Uses

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

Warnings

Do Not Use

  • 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 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 right away.

Directions

  • take preferably at bedtime or as directed by a doctor
    • Age Starting Dosage Maximum Dosage
     adults and children 12 years of age or 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: calcium 25 mg and sodium 3 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid

Questions Or Comments?

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Natural Laxative

Sennosides USP, 8.6 mg

laxative

gentle, overnight relief
natural vegetable laxative ingredient

40 Tablets

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