Search by Drug Name or NDC

NDC 61715-0149-60 Senna-S 50; 8.6 mg/1; mg/1 Details

Senna-S 50; 8.6 mg/1; mg/1

Senna-S is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Kinray Inc.. The primary component is DOCUSATE SODIUM; SENNOSIDES.

MedlinePlus Drug Summary

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 61715-0149-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 61715-0149-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	61715-0149
Product ID	61715-149_2d3fc43a-97ac-4150-8a3c-9980a5ccb3e4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Senna-S
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sennosides 8.6mg and Docusate Sodium 50mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; mg/1
Substance Name	DOCUSATE SODIUM; SENNOSIDES
Labeler Name	Kinray Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61715-0149-60 (61715014960)

Pricing Information	N/A
NDC Package Code	61715-149-60
Billing NDC	61715014960
Package	1 BOTTLE, PLASTIC in 1 CARTON (61715-149-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b0509951-a720-4d4d-85df-1ad1993c05c1 Details

Active ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Docusate sodium 50 mg

Purpose

Laxative

Stool Softener

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 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 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 period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding
you 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 immediately.

Directions

take preferably at bedtime or as directed by a doctor
Adults and children 12 years and over: 2 tablets once a day; maximum 4 tablets twice a day
Children 6 to 12 years of age: 1 tablet once a day; maximum 2 tablets twice a day
Children 2 to under 6 years: 1/2 tablet once a day; maximum 1 tablet twice a day
Children under 2 years of age: ask a doctor

Other information

each tablet contains 8 mg of Calcium, 3 mg Sodium, Very Low Sodium
Store at controlled room temperature 150-300C (590-860F)

Inactive ingredients

Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow #6 , magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc & titanium dioxide.

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

Preferred plus PharmacyTM

NDC 61715-149-60

60 Tablets

Senna-S

(standard senna concentrate

plus docusate sodium)

Gentle Natural

Vegetable Laxative

Compare to the Active Ingredients in Senokot-S®†

INGREDIENTS AND APPEARANCE

SENNA-S

sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61715-149
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (round shape)	Size	10mm
Flavor		Imprint Code	PH32
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61715-149-60	1 in 1 CARTON	08/01/2018
1		60 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	08/01/2018

Labeler - Kinray Inc. (012574513)

Registrant - Pharbest Pharmaceuticals Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceutical Inc.		557054835	analysis(61715-149) , manufacture(61715-149) , pack(61715-149) , label(61715-149)

Revised: 4/2022

Document Id: 2d3fc43a-97ac-4150-8a3c-9980a5ccb3e4

Set id: b0509951-a720-4d4d-85df-1ad1993c05c1

Version: 2

Effective Time: 20220412