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NDC 50804-0484-01 Stimulant Laxative Plus 50; 8.6 mg/1; mg/1 Details

Stimulant Laxative Plus 50; 8.6 mg/1; mg/1

Stimulant Laxative Plus 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 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: 50804-0484-01
Last Updated: 11/30/2022
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: 50804-0484-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	50804-0484
Product ID	50804-484_da93de65-952e-4d1a-9357-37181d7ca120
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	Stimulant Laxative Plus
Proprietary Name Suffix	Stool Softener
Non-Proprietary Name	Docusate sodium, Sennosides
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; mg/1
Substance Name	DOCUSATE SODIUM; 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 50804-0484-01 (50804048401)

Pricing Information	N/A
NDC Package Code	50804-484-01
Billing NDC	50804048401
Package	100 TABLET in 1 BOTTLE, PLASTIC (50804-484-01)
Marketing Start Date	2015-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 667ed195-1619-43cd-bdf2-2b11482b97f0 Details

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

for overnight relief from occasional constipation (irregularity)
generally produces bowel movement in 6 to 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 lasts 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Other information

each tablet contains: calcium 20 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, dibasic calcium phosphate dihydrate, FD&c blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, 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

Overnight Relief

Stimulant Laxative Plus

Stool Softener

Docusate sodium 50 mg

Sennosides 8.6 mg

Tablets

†Compare to active ingredients in Peri-Colace®

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

†This product is not manufactured or distributed by Purdue Products L.P distributor of Peri-Colace®.

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels,com

Product Label

GOOD SENSE Stimulant Laxative Plus Stool Softener

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE PLUS STOOL SOFTENER

docusate sodium, sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-484
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	0806;AV;TCL097;S44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-484-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2015	01/05/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/31/2015	01/05/2024

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

Revised: 10/2021

Document Id: da93de65-952e-4d1a-9357-37181d7ca120

Set id: 667ed195-1619-43cd-bdf2-2b11482b97f0

Version: 4

Effective Time: 20211015