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NDC 70000-0520-01 Senna Plus 50; 8.6 mg/1; mg/1 Details

Senna Plus 50; 8.6 mg/1; mg/1

Senna Plus is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, 110 DBA LEADER. 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: 70000-0520-01
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: 70000-0520-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	70000-0520
Product ID	70000-0520_cc53f049-bcf4-4d17-b5b1-47b6061f618a
Associated GPIs	46991002770320
GCN Sequence Number	048044
GCN Sequence Number Description	sennosides/docusate sodium TABLET 8.6MG-50MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	13483
HICL Sequence Number	021772
HICL Sequence Number Description	SENNOSIDES/DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Senna Plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium 50 mg and Sennosides 8.6 mg
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	CARDINAL HEALTH, 110 DBA LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0520-01 (70000052001)

Pricing Information
NDC Package Code	70000-0520-1
Billing NDC	70000052001
Package	30 BOTTLE, PLASTIC in 1 CARTON (70000-0520-1) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2019-10-23
NDC Exclude Flag	N
Price Per Unit	0.02987
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SENNA PLUS 8.6-50 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4d4101ca-7d78-4712-9b3d-f395f2646c6b Details

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool Softener

Laxative

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 hours

Warnings

Do not use

if you are 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 period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the 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 (1-800-222-1222).

Directions

take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years 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 10 mg, sodium 5 mg, Very Low Sodium
store at 20-25°C(68-77°F); excursions permitted between 15o-30oC (59o-86oF)

Inactive ingredients

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

Questions or comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0520-1

Senna Plus

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

Stool Softener l Laxative

Dual Action

Standardized

Senna Concentrate

COMPARE TO

SENOKOT-S®

active ingredients*

100% Money

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30 TABLETS

INGREDIENTS AND APPEARANCE

SENNA PLUS

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0520
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, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0520-1	30 in 1 CARTON	10/23/2019
1		30 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	10/23/2019

Labeler - CARDINAL HEALTH, 110 DBA LEADER (063997360)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(70000-0520) , analysis(70000-0520) , pack(70000-0520) , label(70000-0520)

Revised: 6/2021

Document Id: cc53f049-bcf4-4d17-b5b1-47b6061f618a

Set id: 4d4101ca-7d78-4712-9b3d-f395f2646c6b

Version: 2

Effective Time: 20210629