SENEXON-S- docusate sodium -sennosides tablet, coated

SENEXON-S by

Drug Labeling and Warnings

SENEXON-S by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., RUGBY LABORATORIES, INC., TIME-CAP LABS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WARNINGS

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

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

PREGNANCY OR BREAST FEEDING

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

PURPOSE

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

QUESTIONS

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

STOP USE

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 INGREDIENT

  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

WHEN USING

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 & ADMINISTRATION

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

INDICATIONS & USAGE

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SENEXON-S  
docusate sodium -sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-675(NDC: 0536-4086)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-675-30	30 in 1 BOTTLE, PLASTIC
2	NDC: 52959-675-60	60 in 1 BOTTLE, PLASTIC
3	NDC: 52959-675-00	100 in 1 BOTTLE, PLASTIC
4	NDC: 52959-675-02	120 in 1 BOTTLE, PLASTIC
5	NDC: 52959-675-08	180 in 1 BOTTLE, PLASTIC

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

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - RUGBY LABORATORIES, INC. (109178264)

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