SENEXON-S- docusate sodium -sennosides tablet, coated
RUGBY LABORATORIES, INC.

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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192R RUGBY SENEXON-S TABLETS 0536-4086

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Do not use if your are taking mineral oil; for longer than one week; when abdominal pain, nausea or vomiting are present

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

Uses: relieves occasional constipation; generally produces bowel movement in 6-12 hours.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium

D-C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD-C yellow #6 aluminum lake, hypromellose,magnesium stearate, microcrystalline cellulose, polyethyleneglycol, sodium benzoate, stearic acide, Titanium dioxide

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage- 1 tablet twice a day

children uner 2 years - ask a doctor

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

1000 CT

SENEXON-S
docusate sodium -sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-4086
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-4086-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/17/2020	01/15/2023
2	NDC:0536-4086-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/17/2020	01/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/16/2011	01/15/2023

Labeler - RUGBY LABORATORIES, INC. (079246066)

Registrant - TIME-CAP LABS, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME-CAP LABS, INC		037052099	manufacture(0536-4086)

Revised: 1/2023

Document Id: f222d8db-0302-4b74-e053-2995a90a19f7

Set id: bb2064aa-b820-4e07-962a-a506145942df

Version: 6

Effective Time: 20230113

RUGBY LABORATORIES, INC.