SENNA-S- docusate sodium and sennosides tablet, film coated

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg
PURPOSE

Purposes

Stool Softener

Laxative
INDICATIONS & USAGE
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
WARNINGS
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

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

Directions

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 tablet once a day	1 tablet twice a day
Children under 2 years	Ask a Doctor	Ask a Doctor

STORAGE AND HANDLING
Other information
- Each tablet contains: Calcium 20 mg, 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 INGREDIENT

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

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

Distributed by:
Cypress Pharmaceutical, Inc.
Morristown, NJ 07960
SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
PRINCIPAL DISPLAY PANEL

NDC: 60258-951-06

Senna-S
Laxative Tablets

Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

Vegetable Laxative Ingredient Plus Stool Softener

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

CYPRESS PHARMACEUTICAL, INC.

60 Tablets

INGREDIENTS AND APPEARANCE

SENNA-S
docusate sodium and sennosides tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 60258-951-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/03/2002

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Pharmaceuticals		055942270	manufacture(60258-951)

Senna-S by