SENNOSIDES- sennosides capsule, liquid filled 
Granules USA 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.

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EXTRA STRENGTH
Senna Softgels
Standerdized Senna Concentrate
Sennosides 17.2 mg

Active Ingredient

(in each softgel)

Sennosides 17.2 mg

Purpose

Laxative

Uses

■ relieves occasional constipation (irregularity)

■ generally produces a bowel movement within 6-12 hours

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.

Package Label Principal Display Panel

100 count

SENNOSIDES 
sennosides capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES17.2 mg  in 17.2 
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SOYBEAN OIL (UNII: 241ATL177A)  
FUMARIC ACID (UNII: 88XHZ13131)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
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:69848-016-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/29/2020
Labeler - Granules USA Inc (137098864)

Revised: 3/2023
Document Id: f5ef4c58-9a6d-2ded-e053-2995a90af6c0
Set id: a619b8f4-1b5d-181b-e053-2995a90ab729
Version: 2
Effective Time: 20230302
 
Granules USA Inc