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NDC 61715-0056-51 Preferred Plus Senna 8.6 mg/1 Details

Preferred Plus Senna 8.6 mg/1

Preferred Plus Senna is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Kinray Inc.. The primary component is 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: 61715-0056-51
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	61715-0056
Product ID	61715-056_57f6c8f0-c0d0-446f-b43a-7ebcb0d6bf96
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	Preferred Plus Senna
Proprietary Name Suffix	Gentle Natural Vegetable Laxative
Non-Proprietary Name	Sennosides
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	8.6
Active Ingredient Units	mg/1
Substance Name	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 61715-0056-51 (61715005651)

Pricing Information	N/A
NDC Package Code	61715-056-51
Billing NDC	61715005651
Package	1 BOTTLE, PLASTIC in 1 CARTON (61715-056-51) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2013-05-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 83947fc8-833c-4fc6-946f-d4f6d11c13ea Details

Active ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6mg

Purpose

Laxative

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.

Ask a doctor before use if you have

stomach pain, nausea, vomiting, noticed a sudden change in bowel habits that continues over a period fo 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
adults - two tablets once a day: maximum 4 tablets twice a day
children (6-12 years): one tablet once a day: maximum 2 tablets twice a day
children(2-6 years): 1/2 tablet once a day: maximum 1 tablet twice a day
children under 2 years: ask a doctor

Other information

each tablet contains 20 mg of calcium
store at room temperature between 150-300C (590-860F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, talc and triacetin.

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

Preferred plus PharmacyTM

NDC 61715-056-51

100 Tablets

Senna Tablets

(standard senna concentrate)

Gentle Natural

Vegetable Laxative

Compare to the Active Ingredient in Senokot®†

INGREDIENTS AND APPEARANCE

PREFERRED PLUS SENNA GENTLE NATURAL VEGETABLE LAXATIVE

sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61715-056
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S8
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61715-056-51	1 in 1 CARTON	05/07/2013
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	05/07/2013

Labeler - Kinray Inc. (012574513)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(61715-056) , analysis(61715-056) , pack(61715-056) , label(61715-056)

Revised: 4/2022

Document Id: 57f6c8f0-c0d0-446f-b43a-7ebcb0d6bf96

Set id: 83947fc8-833c-4fc6-946f-d4f6d11c13ea

Version: 4

Effective Time: 20220412