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

SENNA-S by

Drug Labeling and Warnings

SENNA-S by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

• relieves occasional constipation (irregularity)

• this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you

• have abdominal pain, nausea or vomiting
• are taking mineral oil
• have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor ifyou have

• no bowel movement within 12 hours after use
• rectal bleeding
• these could signs of 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 5 mg, sodium 1 mg
• store at room temperature 15°C-30°C (59°F-86°F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 (tartrazine), FD&C yellow #6, hypromellose, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

HOW SUPPLIED

Product: 71335-0213

NDC: 71335-0213-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-2 120 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-3 60 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-4 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-5 100 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-6 28 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-7 56 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-8 14 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0213-9 20 TABLET, FILM COATED in a BOTTLE

Docusate/ Sennosides 50/8.6 mg Tablet

INGREDIENTS AND APPEARANCE

SENNA-S 
sennosides and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0213(NDC: 49348-156)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	CPC490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0213-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
2	NDC: 71335-0213-6	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
3	NDC: 71335-0213-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
4	NDC: 71335-0213-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
5	NDC: 71335-0213-7	56 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
6	NDC: 71335-0213-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
7	NDC: 71335-0213-5	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
8	NDC: 71335-0213-2	120 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016
9	NDC: 71335-0213-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/01/2016

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0213) , RELABEL(71335-0213)