SENNA PLUS by DIRECTRX SENNA PLUS tablet

SENNA PLUS by

Drug Labeling and Warnings

SENNA PLUS by is a Otc medication manufactured, distributed, or labeled by DIRECTRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Docusate Sodium 50 mg
Sennosides 8.6 mg

INDICATIONS & USAGE

relieves occasional constipation (irregularity)

generally produces bowel movement in 6 to 12 hours

PURPOSE

Docusate Sodium 50 mg
Sennosides 8.6 mg

WARNINGS

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could 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.

INSTRUCTIONS FOR USE

do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

ACTIVE INGREDIENT

each tablet contains: calcium 7 mg

store at room temperature

INACTIVE INGREDIENT

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

DOSAGE & ADMINISTRATION

o not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA PLUS 
senna plus tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-684(NDC:57896-455)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-684-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/06/2019

Labeler - DIRECTRX (079254320)

Registrant - DIRECTRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECTRX		079254320	repack(61919-684)