Senna-S

Drug Labeling and Warnings

Drug Details [pdf]

SENNA-S- docusate sodium and sennosides tablet, film coated 
Lake Erie Medical DBA Quality Care Products 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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Senna-S

Drug Facts

Active ingredients (in each tablet)	Purposes
Docusate Sodium 50 mg	Stool Softener
Sennosides 8.6 mg	Laxative

Uses

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

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor
• laxative products for longer than 1 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 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

• take preferably at bedtime or as directed by a doctor

Age	Starting Dose	Maximum Dose
Adults and children 12 years and older	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 tablets once a day	1 tablet twice a day
Children under 2 years	Ask a Doctor	Ask a Doctor

Other information

• Each tablet contains: Calcium 20 mg
• Each tablet contains: Sodium 4 mg
• Store at Controlled Room Temperature 15°-30° C (59°-86°F). Protect from light and moisture. Dispense in a tight, light-resistant container

Inactive ingredients

Croscarmellose Sodium, D&C Yellow #10, Dextrose, Dicalcium Phosphate, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide

Questions?

If you have any questions or comments, or to report an adverse event or to obtain product information, call 1-800-793-2145.

Distributed by:
Cypress Pharmaceutical, Inc.
Morristown, NJ 07960

SENNA-S 
docusate sodium and sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-353(NDC: 60258-951)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)	Docusate Sodium	50 mg
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX)	Sennosides	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium (UNII: M28OL1HH48)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Dextrose (UNII: IY9XDZ35W2)
Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Hypromelloses (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Benzoate (UNII: OJ245FE5EU)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G55
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-353-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2015	10/11/2019
2	NDC: 55700-353-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	05/03/2002	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(55700-353)

Revised: 11/2019

Document Id: 3bc5f0aa-a9af-41fb-a1a1-5fb3a8236b3c

34390-5

Set id: d6f0a6ff-82af-4b0a-bd8d-71825182abfc

Version: 4

Effective Time: 20191104

 

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