STOOL SOFTENER LAXATIVE- docusate sodium and sennosides tablet

Stool Softener Laxative by

Drug Labeling and Warnings

Stool Softener Laxative by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor
• if you are presently taking mineral oil, 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 lasts 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 could be 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

• 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 older: 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: ask a doctor

Other information

• each tablet contains: calcium 30 mg
• each tablet contains: sodium 6 mg VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT†

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg STOOL SOFTENER

SENNOSIDES 8.6 mg STIMULANT LAXATIVE

For Overnight Relief Of Occasional Constipation

• Effective
• Reliable
• Comfortable

TABLETS

GLUTEN FREE

†This product is not manufactured or distributed by Avrio Health 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 WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.comwww.topcarebrand.com

Product Label

TOPCARE HEALTH Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE 
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-555
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PSD21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-555-10	1 in 1 BOX	07/30/2020
1		100 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 Drug	M007	07/30/2020

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Registrant - P & L Development, LLC (079765031)