FDA Label for Valumeds Natural Laxative

View Indications, Usage & Precautions

Valumeds Natural 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.

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Drug Facts

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779 


Active Ingredient (In Each Tablet)



Sennosides 8.6 mg


Purpose



Laxative


Uses



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

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



AgeStarting DosageMaximum Dosage
adults and children 12 years of age or over2 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 24 mg and sodium 3 mg
  • 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 1-888-333-9792


Principal Display Panel



*COMPARE TO THE ACTIVE

INGREDIENT IN SENOKOT®

Natural Laxative

Sennosides USP, 8.6 mg
Laxative
Gentle, Overnight Relief
Natural Vegetable Laxative Ingredient

Actual Size

100 TABLETS


* Please review the disclaimer below.