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 8.6mg tablet 
Safecor Health, LLC

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Active ingredient

Sennosides 8.6mg

Purpose

Laxative

Uses

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

Warnings

Do not use

 laxative products for longer than one 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 continues over a period of 2 weeks.

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of childen.

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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 and 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	½ 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 50mg
• Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide.

Principal Display Panel

Senna Tablet

Sennosides 8.6mg

Lot: 22A0161

Exp: 2024-11-22

PKG BY: Safecor Health

Woburn, MA

Rev A

SENNA 
sennosides 8.6mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-130(NDC: 69168-371)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-130-01	100 in 1 BOX	12/01/2022	10/01/2024
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M334	12/01/2022	10/01/2024

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		078805287	repack(48433-130) , relabel(48433-130)

Revised: 10/2024

Document Id: 3a20f3e2-4ca0-4852-869f-42caa3309bed

34390-5

Set id: aaa298dc-257a-4593-818a-a0a40a4766bb

Version: 3

Effective Time: 20241002