SENNA- sennosides 8.6 mg tablets tablet

Senna by

Drug Labeling and Warnings

Senna by is a Otc medication manufactured, distributed, or labeled by AACE PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Senna Tablets

Sennosides 8.6 mg

AACE Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT (IN EACH TABLET)

Sennosides 8.6 mg

PURPOSE

Laxative

USES

• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement in 6 to 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 or older	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 docto

OTHER INFORMATION

• each tablet contains: calcium 4 mg, sodium 3 mg
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Senokot®

Senna Tablets

Sennosides 8.6 mg

Natural Vegetable Laxative

Gentle, Overnight Relief of Constipation

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

AACE Pharmaceuticals, Inc. Fairfield, NJ 07004

aacepharma.com

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.

INGREDIENTS AND APPEARANCE

SENNA 
sennosides 8.6 mg tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71406-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	brown (Light brown to grey)	Score	score with uneven pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71406-105-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2019
2	NDC: 71406-105-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/30/2019

Labeler - AACE PHARMACEUTICALS, INC. (080630748)

Establishment
Name	Address	ID/FEI	Business Operations
AACE PHARMACEUTICALS, INC.		080630748	manufacture(71406-105)