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NDC 50804-0631-10 Senna laxative 8.6 mg/1 Details

Senna laxative 8.6 mg/1

Senna laxative is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, 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: 50804-0631-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	50804-0631
Product ID	50804-631_fc4faf21-1ae8-4e87-9ed2-f41c91e8d691
Associated GPIs	46200060200303
GCN Sequence Number	019964
GCN Sequence Number Description	sennosides TABLET 8.6 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	00701
HICL Sequence Number	001289
HICL Sequence Number Description	SENNOSIDES
Brand/Generic	Generic
Proprietary Name	Senna laxative
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sennosides
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	8.6
Active Ingredient Units	mg/1
Substance Name	SENNOSIDES
Labeler Name	Good Sense (Geiss, Destin & Dunn, Inc.)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 50804-0631-10 (50804063110)

Pricing Information	N/A
NDC Package Code	50804-631-10
Billing NDC	50804063110
Package	1 BOTTLE, PLASTIC in 1 BOX (50804-631-10) / 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2019-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfe2da8d-7678-45fa-9661-00a12a358fd4 Details

Active ingredient (in each tablet)

Sennosides 8.6 mg

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 using 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 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

age	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 tablets 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
store at 25oC (77o F); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin*

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Senna Laxative

Standardized Senna Concentrate 8.6 mg

Natural Vegetable Laxative Ingredient

†Compare to active ingredients in Senokot®

Tablets

†This product is not manufactured or distributed by Aviro Health L.P., distributor of Senokot®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product Label

GOOD SENSE Senna Laxative

INGREDIENTS AND APPEARANCE

SENNA LAXATIVE

sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-631
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080;PS;S8
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-631-10	1 in 1 BOX	01/31/2019	01/31/2025
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	01/31/2019	01/31/2025

Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Revised: 10/2022

Document Id: fc4faf21-1ae8-4e87-9ed2-f41c91e8d691

Set id: dfe2da8d-7678-45fa-9661-00a12a358fd4

Version: 3

Effective Time: 20221028