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NDC 61919-0425-60 SENNA 8.6 mg/1 Details

SENNA 8.6 mg/1

SENNA is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRX. 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: 61919-0425-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	61919-0425
Product ID	61919-425_83877e2d-7dfe-d563-e053-2991aa0a96e3
Associated GPIs	46200060200303
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	n/a
Non-Proprietary Name	SENNA
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	8.6
Active Ingredient Units	mg/1
Substance Name	SENNOSIDES A AND B
Labeler Name	DirectRX
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 61919-0425-60 (61919042560)

Pricing Information	N/A
NDC Package Code	61919-425-60
Billing NDC	61919042560
Package	60 TABLET, COATED in 1 BOTTLE (61919-425-60)
Marketing Start Date	2019-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bbff9b05-4864-4211-95cc-94e1f30d6fd5 Details

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Laxative-•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

WARNINGS SECTION

Do Not Use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before use if you have
noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a Doctor/Pharmacist before use if you are
taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When Using this product
do not use for longer than 1 week unless directed by a doctor

Stop Use and ask a doctor
rectal bleeding or failure to have a bowel movement occur after use of a laxative. 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.

DOSAGE & ADMINISTRATION SECTION

• Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

Age	Starting dosage	Maximum dosage
Adults and children over 12 years	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	consult a doctor

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dehydrate), lactose, magnesium stearate, microcrystalline cellulose, tartaric acid.

INDICATIONS & USAGE SECTION

•for relief of occasional constipation and irregularity •this product produces a bowel movement in 6 to 12 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA-LAX

senna-lax tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61919-205(NDC:0603-0282)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TARTARIC ACID (UNII: W4888I119H)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	AZ217
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61919-205-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
2	NDC:61919-205-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

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

SENNA

senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61919-425(NDC:0904-6434)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-425-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/07/2019

Labeler - DirectRX (079254320)

Registrant - DirectRX (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
DirectRX		079254320	repack(61919-205, 61919-425)

Revised: 3/2019

Document Id: 83877e2d-7dfe-d563-e053-2991aa0a96e3

Set id: bbff9b05-4864-4211-95cc-94e1f30d6fd5

Version: 3

Effective Time: 20190307