SENNA TIME- sennosides tablet, coated 
Bryant Ranch Prepack

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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DRUG FACTS

Active ingredient (in each tablet)
Sennosides 8.6 mg

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away

Purpose
Laxative

Uses

Directions: Take preferably at bedtime or as directed by a doctor; if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a dayChildren 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a dayChildren 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a dayChildren under 2 years - ask a doctor

WARNINGS:  Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

 Inactive Ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

HOW SUPPLIED

NDC: 71335-0865-1 100 TABLET in a BOTTLE

NDC: 71335-0865-2 60 TABLET in a BOTTLE

NDC: 71335-0865-3 120 TABLET in a BOTTLE

NDC: 71335-0865-4 56 TABLET in a BOTTLE

NDC: 71335-0865-5 30 TABLET in a BOTTLE

NDC: 71335-0865-6 90 TABLET in a BOTTLE

Sennosides 8.6mg Tablet

Label Image
SENNA TIME 
sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0865(NDC:49483-080)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0865-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
2NDC:71335-0865-260 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
3NDC:71335-0865-3120 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
4NDC:71335-0865-456 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
5NDC:71335-0865-530 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
6NDC:71335-0865-690 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/14/2012
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0865) , RELABEL(71335-0865)

Revised: 5/2022
Document Id: b8b434c0-702d-4bba-b7a7-6cf71c984262
Set id: bdcf37fc-3938-4d3f-b669-35c6939eac4f
Version: 2
Effective Time: 20220510
 
Bryant Ranch Prepack