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NDC 63187-0683-00 Plus Pharma Senna 8.6 mg/1 Details

Plus Pharma Senna 8.6 mg/1

Plus Pharma Senna is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0683-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	63187-0683
Product ID	63187-683_4e48ba59-9b47-4427-9369-43edfe8024f2
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	Plus Pharma Senna
Proprietary Name Suffix	Standardized Senna Concentrate 8.6 mg Sennosides Each
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	Proficient Rx LP
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 63187-0683-00 (63187068300)

Pricing Information	N/A
NDC Package Code	63187-683-00
Billing NDC	63187068300
Package	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-683-00)
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9641cbbb-cf36-4310-b801-026298ae3536 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 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 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 older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years of age	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 20 mg
•: Store at room temperature
•: Do not use if imprinted seal under cap is broken or missing

Inactive ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Questions?

If you have any questions or comments,or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

NDC 63187-683-00

PlusPHARMA

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Senna

Standardized Senna Concentrate

8.6 mg Sennosides Each

Natural Vegetable Laxative Ingredient

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Plus Pharma is not affiliated with the owner of the registered trademark Senokot®.

100 TABLETS

INGREDIENTS AND APPEARANCE

PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH

sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-683(NDC:51645-851)
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM SULFATE (UNII: 0YPR65R21J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND (Biconvex)	Size	9mm
Flavor		Imprint Code	GPI;W2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-683-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016
2	NDC:63187-683-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016
3	NDC:63187-683-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016
4	NDC:63187-683-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/27/2006

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-683) , RELABEL(63187-683)

Revised: 11/2019

Document Id: 4e48ba59-9b47-4427-9369-43edfe8024f2

Set id: 9641cbbb-cf36-4310-b801-026298ae3536

Version: 3

Effective Time: 20191101