STOOL SOFTENER PLUS 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 a bowel movement in 6 to 12 hours.
WarningsDo 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 breastfeeding

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.

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 20mg
- each tablet contains: sodium 6mg VERY LOW SODIUM
- store at 25o C (77o F); excursions permitted between 15o - 30o C (59o - 86o F)
Inactive Ingredients

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

*contains one or more of these ingredients
Questions or comments?

call toll free 1-877-753-3935 Monday - Friday 9AM - 5PM EST
Principal Display Panel

**Compare to the active ingredients in Peri- colace®

Stool Softener with laxative

Docusate Sodium 50 mg
Sennosides 8.6 mg

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

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

Stool softener plus stimulant laxative

STOOL SOFTENER PLUS 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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55315-484-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/2016	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/11/2016	01/01/2021

Labeler - Freds Inc (005866116)

Registrant - P & L Development, LLC (800014821)

Stool Softener plus Laxative by