STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet
Care One (American Sales Company)

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 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 the active ingredients in Peri-Colace®†

STOOL SOFTENER & STIMULANT LAXATIVE

Docusate sodium, 50 mg

AND Sennosides, 8.6 mg

A GENTLE, PREDICTABLE LAXATIVE

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

Product Label

CareOne Stool Softener & Stimulant Laxative

STOOL SOFTENER PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-584
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)
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)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-584-01	1 in 1 BOX	11/30/2016	11/30/2023
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/30/2016	11/30/2023

Labeler - Care One (American Sales Company) (809183973)

Revised: 1/2023

Document Id: c1d97f6b-3e01-4690-ad40-14b7fd64ebdf

Set id: c053890a-0383-487a-ba64-73687ccbd3f5

Version: 4

Effective Time: 20230117

Care One (American Sales Company)