LAXATIVE DOCUSATE SODIUM WITH SENNA- docusate sodium and sennosides tablet, coated

Laxative Docusate Sodium with Senna by

Drug Labeling and Warnings

Laxative Docusate Sodium with Senna by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purposes

Stool softener
Stimulant laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

• adults and children 12 years and over: take 2-4 tablets daily
• children 6 to under 12 years of age: take 1-2 tablets daily
• children 2 to under 6 years of age: take up to 1 tablet daily
• children under 2 years: ask a doctor

Other information

 each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
store between 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

+TopCare® health

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENTS*

Stool Softener + Stimulant Laxative

For Relief Of Occasional Constipation:
Effective
Reliable
Comfortable

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO STVA1120

topcare@topco.com

www.topcarebrand.com

*This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® 2-IN-1.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

Packaging

INGREDIENTS AND APPEARANCE

LAXATIVE DOCUSATE SODIUM WITH SENNA 
docusate sodium and sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-861
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S154
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-861-01	1 in 1 CARTON	05/01/2021
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	05/01/2021

Labeler - TOPCO ASSOCIATES LLC (006935977)