SENNOSIDES AND DOCUSATE SODIUM tablet

Sennosides and Docusate Sodium by

Drug Labeling and Warnings

Sennosides and Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by McKesson Packaging Services a business unit of McKesson Corporation, Legacy Pharmaceutical Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Docusate Sodium 50mg

Sennosides 8.6 mg

Purpose

Docusate Sodium...............Stool Softener

Sennosides.........................Stimulant Laxative

Keep Out of Reach of Children

Uses

• relieves occasional constipation (irregularity)
• generally causes bowel movement in 6-12 hours

Warnings

Do Not Use

• this product if you are presently taking mineral oil, unless directed by a doctor
• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• a sudden change in bowel movements that persists over 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 could be signs of 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 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 the maximum dosage) or decrease dose until you are comfortable.

Age	Starting Dose	Maximum Dose
Adults and children 12 years of age and older	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 2 to under 6 years	1/2 tablet once a day	1 tablets twice a day
Children under 2 years	ask a doctor	ask a doctor

Other Information

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide, **tapioca starch, **tartaric acid

** may contain one or more of these ingredients

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SENNOSIDES AND DOCUSATE SODIUM 
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-432
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, TAPIOCA (UNII: 24SC3U704I)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL;081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63739-432-10	10 in 1 BOX, UNIT-DOSE	11/10/2007
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63739-432-01	25 in 1 BOX, UNIT-DOSE	11/10/2007
2		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63739-432-04	25 in 1 BOX	11/10/2007
3		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/11/2007

Labeler - McKesson Packaging Services a business unit of McKesson Corporation (140529962)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs., Inc.		037052099	MANUFACTURE(63739-432)

Establishment
Name	Address	ID/FEI	Business Operations
McKesson Packaging Services a business unit of McKesson Corporation		140529962	REPACK(63739-432)