SENNA PLUS by Direct_Rx SENNA PLUS tablet

SENNA PLUS by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Docusate Sodium 50 mg
Sennosides 8.6 mg

PURPOSE

Stool softener

Laxative

INDICATIONS & USAGE

relieves occasional constipation (irregularity)

this product generally produces a bowel movement in 6 to 12 hours

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
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.

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

each tablet contains: calcium 20 mg, sodium 6 mg
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
store at room temperature

INACTIVE INGREDIENT

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA PLUS 
senna plus tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-855(NDC:57896-458)
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-855-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/30/2019

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	repack(61919-855)