SENNA LAXATIVE- sennosides tablet 
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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sunmark 451

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

  • this product generally produces a bowel movement in 6 to 12 hours
  • relieves occasional constipation (irregularity)

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over two weeks

Stop use and ask a doctor if

  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of 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

  • do not exceed 8 tablets in 24 hours
AgeStarting DoseMaximum Dose
adults and children 12 years of age and older2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor4 tablets in the morning and 4 tablets at bedtime
children under 12 yearsask a doctor



Other information

  • each tablet contains: calcium 20 mg
  • store at room temperature 15-30C (59-86F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

HOW SUPPLIED

Product: 71335-0026

NDC: 71335-0026-5 30 TABLET in a BOTTLE

NDC: 71335-0026-3 120 TABLET in a BOTTLE

NDC: 71335-0026-6 90 TABLET in a BOTTLE

NDC: 71335-0026-1 100 TABLET in a BOTTLE

NDC: 71335-0026-4 56 TABLET in a BOTTLE

NDC: 71335-0026-2 60 TABLET in a BOTTLE

Sennosides 8.6mg Tablet

Label Image
SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0026(NDC:49348-165)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
Colorbrown (light brown) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 1122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0026-530 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
2NDC:71335-0026-3120 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
3NDC:71335-0026-690 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
4NDC:71335-0026-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
5NDC:71335-0026-456 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
6NDC:71335-0026-260 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/01/201606/01/2020
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0026) , RELABEL(71335-0026)

Revised: 12/2017
Document Id: 08dcd861-a1f9-433c-9229-828f37da2cb8
Set id: 4dbd5e65-0571-40b8-bfa0-20290c6c5df3
Version: 2
Effective Time: 20171228
 
Bryant Ranch Prepack