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  5. Label Information: Senna-s

FDA Label for Senna-s

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USING AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Senna-s Product Label

The following document was submitted to the FDA by the labeler of this product Granulation Technology, Inc.. 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


Purpose



Stool softener

Laxative


Uses



  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

Warnings




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

Stop Using 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.


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 (1-800-222-1222) right away.


Directions



  • Take preferably at bedtime or as directed by a doctor
    • agestarting dosagemaximum dosage
    adults and children
    12 years of age and over     		2 tablets once a day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tablets twice a day
    children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor


Other Information



  • Each tablet contains: Calcium 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients



croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake


Principal Display Panel



NDC 63561-0187-2

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

Docusate Sodium 50 mg Sennosides 8.6 mg - Senna S

Docusate Sodium 50 mg Sennosides 8.6 mg - Senna S


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