Otc - Active Ingredient
active ingredients (each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Stool Softener-stimulant Laxative Tablet, Coated
FDA Label NDC 41226-209
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Stool Softener-stimulant Laxative (NDC 41226-209). 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 otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SODIUM BENZOATE, STEARIC ACID, TITANIUM DIOXIDE.
Otc - Purpose
Stool Softener
Stimulant Laxative
Indications & Usage
RELIEVES OCCASIONAL CONSTIPATION
GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS
Dosage & Administration
Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
ADULTS AND CHILDREN 12 YEARS \
CHILDREN 6 TO UNDER 12 YEARS: 1-2 TABLETS \DAILY \
CHILDREN 2 TO UNDER 6 YEARS;]
1 TABLET DAILY
CHILDREN UNDER 2 YEARS: ASK A DOCTOR
Warnings
DO NOT USE
LAXATIVE PRODUCTS FOR LONGER THAN 1 WEEK UNLESS DIRECTED BY A DOCTOR
IF YOU ARE PRESENTLY TAKING MINERAL OIL, UNLESS DIRECTED BY A DOCTOR
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
kEEP OUT OF REACH OF CHILDREN. iN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
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