SENOKOT-S- standardized senna concentrate and docusate sodium tablet

Senokot-S by

Drug Labeling and Warnings

Senokot-S by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate sodium         50 mg

Sennosides                      8.6 mg

PURPOSE

Purpose

Stool softener

Laxative

WHEN USING

Uses

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

WARNINGS

Warnings

DO NOT USE

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 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

Ask a doctor before use if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

PREGNANCY OR BREAST FEEDING

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 FORMS & STRENGTHS

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	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

HOW SUPPLIED

Other information

• each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

Inactive ingredients dicalcium phosphate,D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

©2018

Avrio Health L.P. Stamford, CT 06901-3431

305027-0A

WARNINGS AND PRECAUTIONS

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

Senokot-S 60 Tablets Carton
NDC: 67618-310-60

INGREDIENTS AND APPEARANCE

SENOKOT-S 
standardized senna concentrate and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-310
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-310-04	1 in 1 CARTON	10/01/1974
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67618-310-01	1 in 1 CARTON	10/01/1974
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 67618-310-30	1 in 1 CARTON	10/01/1974
3		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 67618-310-60	1 in 1 CARTON	10/01/1974
4		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/1974

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Purdue Pharma		250955291	MANUFACTURE(67618-310)