SENEXON-S  - docusate sodium -sennosides  tablet, coated 
H.J. Harkins Company, 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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Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

ASK A DOCTOR BEFORE USE IF YOU HAVE A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER TWO WEEKS

Ask a doctor or pharmacist berfore use if you are taking any other drug.  Laxatives may affect how other drugs work.

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.

If pregnant or breast-feeding, ask a health professional before use.

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

call 1 800 645-2158 9 am - 5 pm Monday - Friday

Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

  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, polyethylene

glycol, sodium benzoate, stearic acide, Titanium dioxide

Directions take preferably at bedtime or as directed by a doctor

If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maxiumum dosage)





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 under 2 years - ask a doctor

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

labelEnter section text here

SENEXON-S  
docusate sodium -sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-675(NDC:0536-4086)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) docusate sodium50 mg
sennosides a and b (UNII: 1B5FPI42EN) (sennosides a and b - UNII:1B5FPI42EN) sennosides a and b8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
COLLOIDAL 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)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-675-3030 in 1 BOTTLE, PLASTIC
2NDC:52959-675-6060 in 1 BOTTLE, PLASTIC
3NDC:52959-675-00100 in 1 BOTTLE, PLASTIC
4NDC:52959-675-02120 in 1 BOTTLE, PLASTIC
5NDC:52959-675-08180 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - RUGBY LABORATORIES, INC. (109178264)
Establishment
NameAddressID/FEIBusiness Operations
TIME-CAP LABS, INC037052099manufacture

Revised: 12/2011
Document Id: e57a4e72-fd3d-44fa-96ca-06ea1d477cc8
Set id: f6e923e8-46e8-4287-bd62-5b954829cd73
Version: 2
Effective Time: 20111229
 
H.J. Harkins Company, Inc.