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 Spirit Pharmaceuticals 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.

Drug Facts




Active Ingredient (In Each Tablet)



Sennosides 8.6 mg


Puropse



Laxative


Uses



  • relieves occasional constipation (irregularity)
  • generally produces 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 lasts over 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 preferably at bedtime or as directed by a doctor
  • Age Starting Dosage Maximum Dosage
     adults and children 12 years of age or over 2 tablets once a day 4 tablets twice a day
     children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
     children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
     children under 2 years ask a doctor ask a doctor


Other Information



  • each tablet contains: calcium 25 mg and sodium 3 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients



Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid


Questions Or Comments?



Call 1-888-287-1915


Principal Display Panel



Natural Laxative

Sennosides USP, 8.6 mg

laxative

gentle, overnight relief
natural vegetable laxative ingredient

40 Tablets


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