SENEXON-S- docusate sodium 50mg and sennosides 8.6mg tablet, film coated

Senexon-S by

Drug Labeling and Warnings

Senexon-S by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool Softener

Laxative

Uses

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

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor
• 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 ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the 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 (1-800-222-1222).

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years and over	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
• store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)

Inactive ingredients

croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions or comments?

1-800-645-2158

PRINCIPAL DISPLAY PANEL

RUGBY

NDC: 0536-1247-10

Compare to the active ingredients in Senokot-S®*

Senexon-S

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

Natural Vegetable Laxative

Ingredient Plus Stool Softener

1000 TABLETS

INGREDIENTS AND APPEARANCE

SENEXON-S 
docusate sodium 50mg and sennosides 8.6mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1247
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1247-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/02/2019
2	NDC: 0536-1247-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/02/2019

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(0536-1247) , analysis(0536-1247) , pack(0536-1247) , label(0536-1247)