Sennosides And Docusate Sodium Tablet, Film Coated
FDA Label NDC 49483-097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Sennosides And Docusate Sodium (NDC 49483-097). 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, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, 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

Otc - Active Ingredient

active ingredients (each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Otc - Purpose

Stool SoftenerStimulant Laxative

Indications & Usage

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

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

Dosage & Administration

ADULTS AND CHILDREN 12 YEARS AND OVER: 2-4 TABLETS ONCE DAILY OR IN DIVIDED DOSESCHILDREN 6 TO UNDER 12 YEARS: 1-2 TABLETS ONCE DAILY OR IN DIVIDED DOSESCHILDREN 2 TO UNDER 6 YEARS; 1/2 -1 TABLET ONCE DAILY OR IN DIVIDED DOSESCHILDREN UNDER 2 YEARS: ASK A DOCTOR

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 - 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

Package Label.Principal Display Panel

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