FDA Label for Vegetable Laxative

View Indications, Usage & Precautions

Vegetable Laxative 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)



Sennosides                        8.6 mg


Purpose



Laxative


Uses



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

Warnings




Do Not Use



  • 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 27.93 mg
  • Store between 20-25°C (68-77°F)

Inactive Ingredients



croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol (PEG) 4000, talc


Principal Display Panel



NDC 63561-0188-1

Vegetable Laxative Label

SENNOSIDES, 8.6 mg LAXATIVE


Compare to Senokot ® Regular Strength Active Ingredients

100 Film-Coated Tablets


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