DOCUSATE SODIUM AND SENNA - docusate sodium and senna tablet, film coated
Bryant Ranch Prepack

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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DRUG FACTS

Active ingredients (in each tablet)Docusate Sodium 50 mgSennosides 8.6 mg

PurposesStool SoftenerStimulant 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.

Stop use and ask a doctor ifyou have rectal bleedingyou fail to have a bowel movement after use of this product.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.

Directionsadults and children 12 years and over: 2-4 tablets once daily or in divided doseschildren 6 to under 12 years: 1-2 tablets once daily or in divided doseschildren 2 to under 6 years: 1/2-1 tablet once daily or in divided doseschildren 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

HOW SUPPLIED

Product: 63629-1342

Docusate/ Sennosides 50/8.6 mg Tablet

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-1342(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)
MICROCRYSTALLINE CELLULOSE (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:63629-1342-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
2	NDC:63629-1342-5	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
3	NDC:63629-1342-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
4	NDC:63629-1342-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
5	NDC:63629-1342-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
6	NDC:63629-1342-6	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
7	NDC:63629-1342-7	56 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
8	NDC:63629-1342-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011
9	NDC:63629-1342-2	120 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	09/24/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/22/2011	09/24/2011

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-1342) , RELABEL(63629-1342)

Revised: 1/2019

Document Id: 303e68b6-1dab-4812-92bc-b9bb5a421846

Set id: f659d0dc-871f-4a21-b7ac-c96f35bd89fa

Version: 1002

Effective Time: 20190101

Bryant Ranch Prepack