Senna-lax Tablet
FDA Label NDC 53041-159

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Senna-lax (NDC 53041-159). 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 ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, ask a health professional before use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

relieves: occasional constipation (irregularity)

Do Not Use

  • laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • abdominal 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

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
  • expect results in 6-12 hours
  • adults and children 12 years and over do not exceed 8 tablets in 24 hours
  • children 6 to under 12 years do not exceed 4 tablets in 24 hours
  • children 2 to under 6 years do not exceed 2 tablets in 24 hours
  • do not exceed the maximum dosage of this product
  •  adults and children 12 years and over2 tablets once daily (maximum: 4 tablets twice a day) 
     children 6 to under 12 years 1 tablet once daily (maximum: 2 tablets twice a day)
     children 2 to under 6 years 1/2 tablet once daily (maximum: 1 tablet twice a day)
     childrem under 2 years ask a doctor

Other Information

  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • avoid excessive humidity

Inactive Ingredients

crospovidone, dextrose, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Pdp

Compare to the active ingredient in SENOKOT®

Senna-Lax

Natural Vegetable Laxative

Sennosides / Laxative

For Gentle, Overnight

Relief of Constipation

100 Tablets

Box (Gdc159)

Box (Gdc159)

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