SENNA- sennosides tablet
STRATEGIC SOURCING SERVICES 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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healthmart 451

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

this product generally produces a bowel movement in 6 to 12 hours
relieves occasional constipation (irregularity)

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you

have abdominal pain, nausea or vomiting
have noticed a sudden change in bowel habits that lasts over two weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use if a laxative. These may indicate a serious condition.

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

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

Directions

do not exceed 8 tablets in 24 hours

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor	4 tablets in the morning and 4 tablets at bedtime
children under 12 years	ask a doctor

Other information

each tablet contains: calcium 40 mg
store at room temperature 15-30C (59-86F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose*, magnesium silicate*, magnesium stearate, mineral oil*, PEG*, silica*, wax*.
*May contain these ingredients.

package label

451

SENNA
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0363
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0363-1	1 in 1 CARTON	01/01/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2018	08/01/2020

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceuticals, Corp		611196254	repack(62011-0363)

Revised: 12/2019

Document Id: 9aa0a10a-50df-4d29-e053-2995a90aa32d

Set id: 6e9c5e94-9b99-706a-e053-2991aa0a052d

Version: 2

Effective Time: 20191226

STRATEGIC SOURCING SERVICES LLC