SENEXON- senna 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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Rugby 191R

Active ingredient (in each tablet) Sennosides 8.6mg

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

uses

relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

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

Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol oil

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

Relieves occasional constipation

Generally produces bowel movement in 6-12 hours

BOTTLE LABEL IMAGE

SENEXON
senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-5904
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-5904-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2006	01/01/2018
2	NDC:0536-5904-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2006	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/09/2006	01/01/2018

Labeler - RUGBY LABORATORIES, INC. (079246066)

Registrant - TIME-CAP LABS, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME-CAP LABS, INC.		037052099	manufacture(0536-5904)

Revised: 11/2019

Document Id: 98568bef-4752-2c36-e053-2995a90a8110

Set id: ffc422f2-a3e0-4b48-8186-a11e4088c85e

Version: 3

Effective Time: 20191127

RUGBY LABORATORIES, INC.