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NDC 17856-0363-02 Senna Tabs 8.6 mg/1 Details

Senna Tabs 8.6 mg/1

Senna Tabs is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is SENNOSIDES A AND B.

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: 17856-0363-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	17856-0363
Product ID	17856-0363_1d19ec73-2fb4-4b7f-ad27-227bcc7dbd3b
Associated GPIs
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 Tabs
Proprietary Name Suffix	n/a
Non-Proprietary Name	Senna
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 A AND B
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-0363-02 (17856036302)

Pricing Information	N/A
NDC Package Code	17856-0363-2
Billing NDC	17856036302
Package	100 POUCH in 1 BOX, UNIT-DOSE (17856-0363-2) / 1 TABLET, FILM COATED in 1 POUCH (17856-0363-4)
Marketing Start Date	2022-09-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe Details

Active ingredient (in each tablet)

Sennosides 8.6mg

Purpose

Laxative

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

for more than one week unless directed by a doctor

Ask a doctor before use if you

have abdominal pain, nausea, or vomiting
are taking mineral oil
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have no bowel movement within 12 hours
you have rectal bleeding

These could be signs of 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

do not exceed recommended dose

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor	4 tablets twice a day, in the morning and at bedtime
children under 12 years	ask a doctor	ask a doctor

Other information

Tamper Evident: Do not use if safety seal under cap is broken or missing
each tablet contains: calcium 20 mg, potassium 70 mg
store at room temperature

INACTIVE INGREDIENTS:

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

Adverse drug event call: (866) 562-2756

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA TABS

senna tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-0363(NDC:16103-363)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S8
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-0363-1	100 in 1 BOX, UNIT-DOSE	09/22/2022
1	NDC:17856-0363-3	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:17856-0363-2	100 in 1 BOX, UNIT-DOSE	09/22/2022
2	NDC:17856-0363-4	1 in 1 POUCH; 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	01/24/2007

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS		360804194	repack(17856-0363)

Revised: 9/2022

Document Id: 1d19ec73-2fb4-4b7f-ad27-227bcc7dbd3b

Set id: cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe

Version: 2

Effective Time: 20220922