STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet
EQUALINE (SuperValu)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 a bowel movement in 6 to 12 hours

Warnings

Do not use

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently 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 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 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	ask a doctor

Other information

each tablet contains: calcium 20 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 15º-30ºC (59º-86ºF), protect from excessive moisture

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid, talc*, titanium dioxide, triglycerides*

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

COMPARE TO PERI-COLACE® ACTIVE INGREDIENTS†

Stool Softener Plus Stimulant Laxative

Docusate Sodium 50 mg/ Sennosides 8.6 mg

For Overnight Relief of Occasional Constipation

Effective, Reliable, Comfortable

Tablets

†This product is not manufactured or distributed Purdue Products L.P., owner of the registered trademark Peri-Colace®

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

DISTRIBUTED BY:

SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

Product Label

Stool softener plus stimulant laxative

STOOL SOFTENER PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-629
Route of Administration	ORAL

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)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097;SS2;S44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-629-62	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2010	12/31/2019
2	NDC:41163-629-63	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2010	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	09/15/2010	12/31/2019

Labeler - EQUALINE (SuperValu) (006961411)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2014

Document Id: 6c5cfe49-5cc8-4800-acb9-5105ec0d941a

Set id: 21f8ea1e-38fe-4c93-854e-6cff16a0f2d3

Version: 3

Effective Time: 20141222

EQUALINE (SuperValu)