FDA Label for Stool Softener Plus Stimulant Laxative
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS (IN EACH TABLET)DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG
- PURPOSESTOOL SOFTENER STIMULANT LAXATIVE
- USES■ RELIEVES OCCASIONAL CONSTIPATION (IRREGULARITY) ■ GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS
- WARNINGSDO 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
- ASK A DOCTOR BEFORE USE IF YOU HAVE ■ STOMACH PAIN ■ NAUSEA ■ VOMITING ■ NOTICED A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER 2 WEEKS
- STOP USE AND ASK A DOCTORIF YOU HAVE RECTAL BLEEDING OR FAIL TO HAVE A BOWEL MOVEMENT AFTER USE OF A LAXATIVE. THESE COULD BE SIGNS OF 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 RIGHT AWAY 1-800-222-1222
- DIRECTIONS ■ 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 AND OVER TAKE 2-4 TABLETS DAILY CHILDREN 6 TO UNDER 12 YEARS OF AGE TAKE 1-2 TABLETS DAILY CHILDREN 2 TO UNDER 6 YEARS OF AGE TAKE UP TO 1 TABLET DAILY CHILDREN UNDER 2 ASK A DOCTOR
- OTHER INFORMATION ■ EACH TABLET CONTAINS:CALCIUM 20 MG, SODIUM 6 MG ■ STORE AT 25°C (77°F); EXCURSIONS PERMITTED BETWEEN 15°-30°C (59°-86°F)
- INACTIVE INGREDIENTSCOLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, DICALCIUM PHOSPHATE, FD&C RED #40, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, TITANIUMDIOXIDE
- QUESTIONS OR COMMENTS?1-888-333-9792
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Stool Softener Plus Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredients (In Each Tablet)Docusate Sodium 50 Mg Sennosides 8.6 Mg
Purposestool Softener Stimulant Laxative
Uses■ Relieves Occasional Constipation (Irregularity) ■ Generally Produces Bowel Movement In 6-12 Hours
Warningsdo 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
Ask A Doctor Before Use If You Have ■ Stomach Pain ■ Nausea ■ Vomiting ■ Noticed A Sudden Change In Bowel Habits That Lasts Over 2 Weeks
Stop Use And Ask A Doctorif You Have Rectal Bleeding Or Fail To Have A Bowel Movement After Use Of A Laxative. These Could Be Signs Of 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 Right Away 1-800-222-1222
Directions ■ 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 And Over Take 2-4 Tablets Daily Children 6 To Under 12 Years Of Age Take 1-2 Tablets Daily Children 2 To Under 6 Years Of Age Take Up To 1 Tablet Daily Children Under 2 Ask A Doctor
Other Information ■ Each Tablet Contains:Calcium 20 Mg, Sodium 6 Mg ■ Store At 25°C (77°F); Excursions Permitted Between 15°-30°C (59°-86°F)
Inactive Ingredientscolloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Fd&C Red #40, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Purified Water, Stearic Acid, Titaniumdioxide
Questions Or Comments?1-888-333-9792
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