Active Ingredient
Sennosides
Sennosides
FDA Label NDC 83813-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newvue Llc for the product Sennosides (NDC 83813-004). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Uses
For relief of occasional constipation and irregularity.
This product produces a bowel movement in 6 to 12 hours.
Warnings
Do not use laxative products for more than one week unless directed by a doctor
Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks.
Stop use and ask a doctor ifrectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.
If Pregnant or breast-feedingask a health professional before use.
Directions
Take preferably at bedtime or as directed by a doctor.
Adults and children over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day.
Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day.
Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day.
Children under 2: consult a doctor
Inactive Ingredients
croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.
* Please review the disclaimer below.
