Active Ingredient (In Each Tablet)
Sennosides 15 mg
Laxative Tablet, Sugar Coated
FDA Label NDC 37835-214
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Laxative (NDC 37835-214). 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, ask a doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Do Not Use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask A Doctor Before Use If You Have
noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Ask A Doctor Or Pharmacist Before Use If You
are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
When Using This Product
do not use for a period longer than 1 week.
Stop Use And Ask A Doctor If
rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may bindicate a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- swallow tablets with a glass of water
- swallow tablets whole; do not crush, break, or chew
| adults and children 12 years of age and older | Take 2 tablets once or twice daily |
| children 6 to under 12 years of age | Take 1 tablet once or twice daily |
| children under 6 years of age | Ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF SEAL AROUND TABLET IS BROKEN OR DAMAGED
- each tablet contains:calcium 35 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, maltodextrin**, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide. **may contain this ingredient
Questions?
call toll-freee 1-844-912-4012
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