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NDC 41163-0782-10 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 EQUALINE (SuperValu). 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: 41163-0782-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	41163-0782
Product ID	41163-782_656ab69f-1ef8-4c3b-a059-17a4212ac5bf
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 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	EQUALINE (SuperValu)
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 41163-0782-10 (41163078210)

Pricing Information	N/A
NDC Package Code	41163-782-10
Billing NDC	41163078210
Package	1 BOTTLE, PLASTIC in 1 BOX (41163-782-10) / 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-10-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2490905c-5262-4381-81e4-77580d158875 Details

Active ingredients (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

relieves occasional constipation (irregularity)
generally produces 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 (1-800-222-1222) 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 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 30 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

dibasic calcium phosphate dihydrate, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin

Questions or comments?

Call toll free 1-855-423-2630

Principal Display Panel

compare to Senokot® active ingredient†

regular strength

senna laxative

sennosides 8.6 mg each

natural vegetable laxative ingredient

tablets

†This product is not manufactured ir distributed by Avrio 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 UNFI

PROVIDENCE, RI 02908 USA

Product Labeling

EQUALINE Senna Laxative

INGREDIENTS AND APPEARANCE

SENNA LAXATIVE

sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-782
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	PS23
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-782-10	1 in 1 BOX	10/29/2021
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	10/29/2021

Labeler - EQUALINE (SuperValu) (006961411)

Revised: 11/2022

Document Id: 656ab69f-1ef8-4c3b-a059-17a4212ac5bf

Set id: 2490905c-5262-4381-81e4-77580d158875

Version: 2

Effective Time: 20221107