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
|
SENEXON
senna tablet, coated |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0536-5904 |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) | SENNOSIDES A AND B | 8.6 mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| 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 | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 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 Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part334 | 02/09/2006 | 01/01/2018 |
|
| Labeler - RUGBY LABORATORIES, INC.
(079246066)
|
| Registrant - TIME-CAP LABS, INC (037052099) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| TIME-CAP LABS, INC. | | 037052099 | manufacture(0536-5904) |
RUGBY LABORATORIES, INC.
