STOOL SOFTENER WITH 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 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 30 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, microcrystalline cellulose, polyethylene glycol*, 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

stool softener + stimulant laxative

docusate sodium 50 mg

(stool softener )

sennosides 8.6 mg

(stimulant laxative)

tablets

†Compare to the active ingredients in Colace® 2-IN-1

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

†This product is not manufactured or distributed by Avrio Health LP., distributor of Colace® 2-IN-1

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590
Product Label

WELLNESS BASICS Stool Softener plus Stimulant Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER WITH 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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59726-729-40	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	09/30/2018

Labeler - P & L Development, LLC (800014821)

Stool Softener with Stimulant Laxative by