SENNA by Safecor Health, LLC

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA- sennosides tablet, coated 
Safecor Health, LLC

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-301(NDC: 49483-080)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-301-10	100 in 1 BOX, UNIT-DOSE	09/30/2014	11/11/2019
1	NDC: 48433-301-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/30/2014	11/11/2019

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	REPACK(48433-301)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		078805287	REPACK(48433-301)

Revised: 11/2019

Document Id: 218791c6-f56a-488d-b53f-f1af03b44df7

34390-5

Set id: 45680e44-1ec1-48ed-81da-7b735ab09b47

Version: 2

Effective Time: 20191126

 

Safecor Health, LLC