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SENNA by Safecor Health, LLC

Dosage form: tablet, coated
Ingredients: SENNOSIDES A AND B 8.6mg
Labeler: Safecor Health, LLC
NDC Code: 48433-301

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.

Each tablet contains:  Sennosides 8.6 mg

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away


PURPOSE:  LAXATIVE

Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

Directions:

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

Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a day

Children 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day

Children under 2 years - ask a doctor

WARNINGS: 

Do not use laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have abdominal pain, nausea, vomiting, or noticed 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 might affect how other drugs work. Take this product 2 or more hours before or after other drugs.

Stop use and ask a doctor ifyou haverectal 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 care professional before use.

 Inactive Ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

SENNA 
sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-301(NDC:49483-080)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeTCL080
Contains    
Packaging
#Item CodePackage Description
1NDC:48433-301-10100 POUCH in 1 BOX, UNIT-DOSE
1NDC:48433-301-011 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/30/2014
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC828269675REPACK(48433-301)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC078805287REPACK(48433-301)

 
Safecor Health, LLC

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Medically reviewed on May 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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