STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet

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 told to do so 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 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 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
Principal Display Panel

Compare to Peri-Colace® active ingredient†

stool softener

Plus Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

For Relief of Occasional Constipation

TABLETS

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

†This product is not manufactured or distributed by Purdue Products LP., distributor of Peri-Colace®.

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313
Product Label

Leader Stool Softener Plus Stimulant Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49781-150-51	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2016	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/31/2016	12/31/2020

Labeler - Cardinal Health (Leader) 49781 (097537435)

Stool Softener by