SENNOSIDES,DOCUSATE SODIUM tablet, film coated

Sennosides,Docusate sodium by

Drug Labeling and Warnings

Sennosides,Docusate sodium by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Sennosides 8.6 mg

Docusate sodium 50 mg

PURPOSE

Purposes

Laxative

Stool softener

Uses

• relieves occasional constipation (irregularity)
• generally produces 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 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 tablets 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

Other information

■ each tablet contains: calcium 11 mg

■ each tablet contains: sodium 4 mg

■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake†, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin

†contains FD&C yellow #5 lake (tartrazine) as a color additive.

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT

*Rugby Laboratories is not affiliated with the owner of the registered trademark Senokot-S.®

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

SENNOSIDES,DOCUSATE SODIUM 
sennosides,docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-8276(NDC:0536-1169)
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-8276-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/20/2018

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-8276)