STOOL SOFTENER WITH STIMULANT LAXATIVE- docusate sodium and sennosides tablet

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. 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

• for overnight relief from 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 now taking mineral oil, unless told to do so 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 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 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 20 mg
• each tablet contains: sodium 6 mg VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15-30ºC(59-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

Product: 63629-7532

NDC: 63629-7532-1 30 TABLET in a BOTTLE

Docusate 50/ 8.6mg Tablet

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  WITH STIMULANT LAXATIVE
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-7532(NDC:49348-013)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097;0806;AV;S44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-7532-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/31/2016

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-7532) , RELABEL(63629-7532)