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  5. Label Information: Laxative Docusate Sodium With Senna

FDA Label for Laxative Docusate Sodium With Senna

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON

Laxative Docusate Sodium With Senna Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each tablet)Purposes
Docusate sodium 50 mgStool softener
Sennosides 8.6 mgStimulant laxative

Uses



  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

Do Not Use



  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week 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 continues over a period of 2 weeks

Otc - Stop Use



Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


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.


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 overtake 2-4 tablets daily
    children 6 to under 12 years of agetake 1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily
    children under 2 yearsask a doctor

Other Information



  • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
  • store between 20-25°C (68-77°F)

Inactive Ingredients



colloidal silicon dioxide, crosscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide


Questions?



Call 1-888-423-0139


Principal Display Panel - 100 Tablet Bottle Carton



NDC 36800-154-01

*Compare to the active ingredients
in Colace® 2-IN-1

Stool
Softener
+ Stimulant
Laxative

DOCUSATE SODIUM 50 mg
STOOL SOFTENER

SENNOSIDES 8.6 mg
STIMULANT LAXATIVE

For Relief of
Occasional Constipation

* Please review the disclaimer below.