SENNOSIDES- sennosides capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

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.

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Sennosides 17.2 mg Softgels (Senna)

Actice ingredient

(in each softgel)
Sennosides 17.2 mg

Purpose

Laxative

Uses

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

Other Information

store below 30°C (86°F) 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

Shipper labelPack label

SENNOSIDES 
sennosides capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0423
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES17.2 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (Maroon coloured, opaque soft gelatin capsules containing dark brown coloured oily mass) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0423-11000 in 1 BAG; Type 0: Not a Combination Product05/29/2019
2NDC:35916-0423-22000 in 1 BOX; Type 0: Not a Combination Product05/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/29/2019
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0423)

Revised: 1/2023
Document Id: f1f68723-3021-8405-e053-2995a90a5be8
Set id: 94936bd4-8bbf-6211-e053-2995a90a2138
Version: 5
Effective Time: 20230110
 
SOFTGEL HEALTHCARE PRIVATE LIMITED