SENNOSIDES- sennosides tablet 
New World Imports, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Sennosides

Laxative

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

For relief of occasional constipation and irregularity.

This product produces a bowel movement in 6 to 12 hours.

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor or pharmacist before use if you are taking a prescription drug.  Laxatives may affect how other drugs work.  Take this product 2 or more hours before or after other drugs.

When using this product do not use for longer than 1 week unless directed by a doctor

Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative.  These could be signs of a serious condition.

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

Take preferably at bedtime or as directed by a doctor.  If you do not have comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults and children over 12 years: 2 tablets once a day.  Maximum of 4 tablets twice a day.

Children 6 to under 12 years: 1 tablet once a day.  Maximum of 2 tablets twice a day.

Children 2 to under 6 years: 1/2 tablet once a day.  Maximum of 1 tablet twice a day.

Children under 2: consult a doctor


Colloidal silicon dioxide, croscarmellose sodium, dibasic dicalcium phosphate dihydrate, lactose, magnesium stearate, microcrystalline cellulose, and tartaric acid.

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SENNOSIDES 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-217
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sennosides a and b (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) sennosides a and b8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Magnesium stearate (UNII: 70097M6I30)  
Cellulose, microcrystalline (UNII: OP1R32D61U)  
Product Characteristics
Colorbrown (Speckled various shades of brown) Scoreno score
ShapeROUND (Round) Size8mm
FlavorImprint Code AZ;217
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-217-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/10/201007/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/10/201007/01/2020
Labeler - New World Imports, Inc (075372276)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930manufacture(51824-217)

Revised: 10/2019
 
New World Imports, Inc