LAXATIVE STOOL SOFTENER- docusate sodium, sennosides tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG), SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)
Available from:
CVS Pharmacy
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stool softener Laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 6-12 hours
Authorization status:
OTC monograph not final
Authorization number:
69842-830-18, 69842-830-30

LAXATIVE STOOL SOFTENER- docusate sodium, sennosides tablet

CVS Pharmacy

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.

----------

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpos e

Stool softener

Laxative

Us es

relieves occasional constipation (irregularity)

generally produces bowel movement in 6-12 hours

Warnings

Do not use

if you are now taking mineral oil, unless directed by a doctor

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that continues over a periodof 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 preferably at bedtime or as directed by a doctor

starting dosage

maximum dosage

adults and children 12 years of age and

over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

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, D&C yellow #10 aluminum lake, dibasic calcium phosphate

dihydrate, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, silicon 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 Senokot-S®†

Senna Plus

DOCUSATE SODIUM, 50 mg

SENNOSIDES, 8.6 mg

Laxative/Stool softener

Natural vegetable laxative ingredient plus stool softener

TABLETS

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 L.P., distributor of Senokot-S®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Labeling

CVS HEALTH Senna Plus

LAXATIVE STOOL SOFTENER

docusate sodium, sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-8 30

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)

DOCUSATE SODIUM

50 mg

SENNO SIDES (UNII: 3FYP5M0 IJX) (SENNOSIDES - UNII:3FYP5M0 IJX)

SENNOSIDES

8 .6 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

CVS Pharmacy

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

TCL0 8 1;PSD21;S35

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 42-8 30 -

1 in 1 BOX

0 5/0 1/20 19

1

30 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:6 9 8 42-8 30 -

18 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

0 5/0 1/20 19

Labeler -

CVS Pharmacy (062312574)

Revised: 5/2019

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