SENNOSIDES capsule, liquid filled

Sennosides by

Drug Labeling and Warnings

Sennosides by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actice ingredient

(in each softgel)
Sennosides 17.2 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement within 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 consult 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 adults and children 12 years and over
• 1 capsule once a day. Maximum 2 capsules twice a day. children 6 to under 12 years
• maximum 1 capsule twice a day children under 6 years
• ask a doctor

Other Information

store below 30°C and protect from light and moisture

Inactive ingredients

FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, yellow bees wax.

Questions or comments?

call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNOSIDES 
sennosides capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0423
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	17.2 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
FUMARIC ACID (UNII: 88XHZ13131)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
YELLOW WAX (UNII: 2ZA36H0S2V)
SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics
Color	brown (Maroon coloured, opaque soft gelatin capsules containing dark brown coloured oily mass)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0423-1	1000 in 1 BAG; Type 0: Not a Combination Product	05/29/2019
2	NDC: 35916-0423-2	2000 in 1 BOX; Type 0: Not a Combination Product	05/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/29/2019

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(35916-0423)