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NDC 71335-0977-02 Senna Plus 50; 8.6 mg/1; mg/1 Details

Senna Plus 50; 8.6 mg/1; mg/1

Senna Plus is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is DOCUSATE SODIUM; SENNOSIDES.

MedlinePlus Drug Summary

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 71335-0977-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 71335-0977-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	71335-0977
Product ID	71335-0977_12ad5d15-a889-41c0-afb1-fed9b1af8553
Associated GPIs	46991002770320
GCN Sequence Number	048044
GCN Sequence Number Description	sennosides/docusate sodium TABLET 8.6MG-50MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	13483
HICL Sequence Number	021772
HICL Sequence Number Description	SENNOSIDES/DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Senna Plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sennosides and Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; mg/1
Substance Name	DOCUSATE SODIUM; SENNOSIDES
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-0977-02 (71335097702)

Pricing Information	N/A
NDC Package Code	71335-0977-2
Billing NDC	71335097702
Package	120 TABLET, FILM COATED in 1 BOTTLE (71335-0977-2)
Marketing Start Date	2018-11-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1577c4e5-bc35-48db-b16f-49d6b684d8a2 Details

Active ingredient (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 6 to 12 hours

Warnings

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

Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could 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

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

• each tablet contains: calcium 7 mg

• store at room temperature

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

HOW SUPPLIED

NDC: 71335-0977-1: 30 Tablets in a BOTTLE

NDC: 71335-0977-2: 120 Tablets in a BOTTLE

NDC: 71335-0977-3: 60 Tablets in a BOTTLE

NDC: 71335-0977-4: 90 Tablets in a BOTTLE

NDC: 71335-0977-5: 100 Tablets in a BOTTLE

NDC: 71335-0977-6: 28 Tablets in a BOTTLE

NDC: 71335-0977-7: 56 Tablets in a BOTTLE

NDC: 71335-0977-8: 14 Tablets in a BOTTLE

NDC: 71335-0977-9: 20 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Docusate/ Sennosides 50/8.6 mg Tablet

INGREDIENTS AND APPEARANCE

SENNA PLUS

sennosides and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0977(NDC:57896-455)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0977-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2019
2	NDC:71335-0977-2	120 in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2018
3	NDC:71335-0977-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2018
4	NDC:71335-0977-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2022
5	NDC:71335-0977-5	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2018
6	NDC:71335-0977-6	28 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2018
7	NDC:71335-0977-7	56 in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2022
8	NDC:71335-0977-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2022
9	NDC:71335-0977-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0977) , RELABEL(71335-0977)

Revised: 6/2022

Document Id: 12ad5d15-a889-41c0-afb1-fed9b1af8553

Set id: 1577c4e5-bc35-48db-b16f-49d6b684d8a2

Version: 4

Effective Time: 20220629