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NDC 45865-0992-60 Senna 8.6 mg/1 Details

Senna 8.6 mg/1

Senna is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by medsource pharmaceuticals. 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: 45865-0992-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	45865-0992
Product ID	45865-992_9af2f05c-0e3d-716c-e053-2a95a90a3d45
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	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	medsource pharmaceuticals
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 45865-0992-60 (45865099260)

Pricing Information	N/A
NDC Package Code	45865-992-60
Billing NDC	45865099260
Package	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-992-60)
Marketing Start Date	2019-12-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9af25838-77fa-f9f2-e053-2a95a90ab6af 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

INGREDIENTS AND APPEARANCE

SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH

sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45865-992(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)
CELLULOSE, MICROCRYSTALLINE (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:45865-992-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2019
2	NDC:45865-992-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2019

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

Labeler - medsource pharmaceuticals (833685915)

Name	Address	ID/FEI	Business Operations
Establishment
medsource pharmaceuticals		833685915	repack(45865-992)

Revised: 12/2019

Document Id: 9af2f05c-0e3d-716c-e053-2a95a90a3d45

Set id: 9af25838-77fa-f9f2-e053-2a95a90ab6af

Version: 1

Effective Time: 20191230