SENNA PLUS- sennosides and docusate sodium 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.

----------

gc 455t (458)

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you

Stop use and ask a doctor if you have

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

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

Other information

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

HOW SUPPLIED

NDC: 71335-1181-1: 30 Tablets in a BOTTLE

NDC: 71335-1181-2: 120 Tablets in a BOTTLE

NDC: 71335-1181-3: 60 Tablets in a BOTTLE

NDC: 71335-1181-4: 90 Tablets in a BOTTLE

NDC: 71335-1181-5: 100 Tablets in a BOTTLE

NDC: 71335-1181-6: 28 Tablets in a BOTTLE

NDC: 71335-1181-7: 56 Tablets in a BOTTLE

NDC: 71335-1181-8: 14 Tablets in a BOTTLE

NDC: 71335-1181-9: 20 Tablets in a BOTTLE

Docusate/ Sennosides 50/8.6 mg Tablet

Label
SENNA PLUS 
sennosides and docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1181(NDC:57896-458)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1181-130 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2021
2NDC:71335-1181-2120 in 1 BOTTLE; Type 0: Not a Combination Product02/05/2020
3NDC:71335-1181-360 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
4NDC:71335-1181-490 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
5NDC:71335-1181-5100 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2019
6NDC:71335-1181-628 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2019
7NDC:71335-1181-756 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
8NDC:71335-1181-814 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
9NDC:71335-1181-920 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2000
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1181) , RELABEL(71335-1181)

Revised: 2/2022
Document Id: 5f3b3624-f7a7-4cdf-8c23-d1bdea9b8038
Set id: 5f3b3624-f7a7-4cdf-8c23-d1bdea9b8038
Version: 2
Effective Time: 20220214
 
Bryant Ranch Prepack