SENNA- sennosides capsule, gelatin coated

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by CVS, Spirit Pharmaceuticals LLC, MEDGEL PRIVATE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)                                    Purpose

Sennosides 8.6 mg..............................................................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 lasts over 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 softgels once a day	4 softgels twice a day
children 6 to under 12 years	1 softgel once a day	2 softgels twice a day
children under 6 years of age	ask a doctor	ask a doctor

Other information

• each softgel contains: calcium 1 mg and sodim less than 1  mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No.6, gelatin, glycerin, light liquid paraffin, purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions?

Call 1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton

♥CVSHealth ™

Compare to the active
ingredient in Senokot ®*

Liquid Filled Softgels†

NDC: 69842-320-60

Senna
SENNOSIDES, 8.6 mg
Laxative

Standardized senna concentrate

Natural vegetable

laxative ingredient

60 SOFTGELS

Actual Product Size

on Bottom Panel

INGREDIENTS AND APPEARANCE

SENNA 
sennosides capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-320
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown (Opaque)	Score	no score
Shape	CAPSULE (SOFTGEL)	Size	12mm
Flavor		Imprint Code	458
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-320-60	1 in 1 CARTON	03/14/2018
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/14/2018

Labeler - CVS (062312574)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(69842-320)