DOCUSATE SODIUM AND SENNA- docusate sodium and senna tablet, film 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 243R -

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool Softener

Stimulant Laxative

Uses

relieves occasional constipation
generally produces bowel movement in 6-12 hours

Warnings

Do not use

for longer than one week
if you are taking mineral oil
when abdominal pain, nausea or vomiting are present

Ask a doctor before use if you have

noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

adults and children 12 years and over: 2-4 tablets once daily or in divided doses

children 6 to under 12 years: 1-2 tablets once daily or in divided doses

children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses

children under 2 years: ask a doctor

Other information

each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at 20°-25°C (68°-77°F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

call

1-800-645-2158,

9 am - 5 pm ET, Monday - Friday

DOCUSATE SODIUM AND SENNA
docusate sodium and senna tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-0355
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 (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple (burgundy)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;131
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-0355-01	100 in 1 BOX; Type 0: Not a Combination Product	09/22/2011	01/01/2018
2	NDC:0536-0355-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/22/2011	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(0536-0355)

Revised: 11/2019

Document Id: 97f1e781-dfce-825a-e053-2a95a90afe91

Set id: 20e2b40b-1274-4f0a-b8af-edfb0d5d3270

Version: 2

Effective Time: 20191122

Rugby Laboratories, Inc