SENNA S- sennosides and sodium dioctylsulfosuccinate tablet
Contract Pharmacal Corp.

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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0490

SPL UNCLASSIFIED

GENTLE NATURAL VEGETABLE LAXATIVE

Compare to the Active Ingredients in Senokot-S®†

1000 Tablets

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

Drug Facts

Active Ingredients

(in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purposes

Laxative

Stool Softener

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 hours

Warnings

Do not use

laxative products for longer than 1 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 2 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 care 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 preferably at bedtime or as directed by a doctor.

age	starting dosage	maximum dosage
dults and children over 12 years	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children under 6 years	ask a doctor

Other information store at room temperature, USP.

Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow #5* Lake, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Starch, Stearic Acid and Titanium Dioxide.

*Contains FD&C Yellow #5 Lake (Tartrazine) as a color additive.

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SENNA S
sennosides and sodium dioctylsulfosuccinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-0490
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	8.5 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	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:10267-0490-7	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2001	03/31/2015
2	NDC:10267-0490-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2001	01/31/2008
3	NDC:10267-0490-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2001	03/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/05/2001	03/31/2015

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-0490)

Revised: 10/2017

Document Id: 5c89937d-246b-902e-e053-2a91aa0accf4

Set id: bee68d51-be9b-470f-885a-a316d809eef3

Version: 2

Effective Time: 20171027

Contract Pharmacal Corp.