SENNOSIDES, DOCUSATE SODIUM- sennosides, docusate sodium tablet, film coated
Rugby Laboratories

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.

----------

3052C-Rugby

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool softener

Stimulant laxative

Uses

for overnight relief from occasional constipation (irregularity) 
generally produces bowel movement in 6-12 hours

Do not use

laxative products for longer than one week, unless directed by a doctor 
if you are now taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have 

stomach pain 
nausea 
vomiting 
noticed a sudden change in bowel habits that continues over a period of two weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and older	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Other information

each tablet contains: calcium 11 mg 
each tablet contains: sodium 4 mg (VERY LOW SODIUM) 
store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin

Questions or comments?

1- 800-645-2158

*Rugby Laboratories is not afliated with the owner of the trademark Colace® 2-IN-1

SAVE CARTON FOR COMPLETE DRUG FACTS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rugby ®

NDC 0536-1167-01

COMPARE TO THE ACTIVE INGREDIENTS IN COLACE® 2-IN-1.*

Docusate Sodium 50 mg & Senna 8.6 mg

Stimulant Laxative Plus Stool Softener

100 Tablets

3052C-rugby-label

SENNOSIDES, DOCUSATE SODIUM
sennosides, docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1167
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TRIACETIN (UNII: XHX3C3X673)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1167-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019	12/31/2021
2	NDC:0536-1167-01	1 in 1 CARTON	01/31/2019	04/30/2022
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/31/2019	04/30/2022

Labeler - Rugby Laboratories (079246066)

Revised: 10/2019

Document Id: 95213cd4-d08c-4400-e053-2995a90ad490

Set id: 79006a7f-9c25-0530-e053-2a91aa0a8ffe

Version: 3

Effective Time: 20191017

Rugby Laboratories