SENNA PLUS- sennosides and docusate sodium tablet

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg
Purpose

Stool softener

Laxative
Uses
- 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.

Directions

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 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 ingredients

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.
PRINCIPAL DISPLAY PANEL
DRUG: Senna Plus

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2462-0

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: TCL081

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):
- DOCUSATE SODIUM 50mg in 1
- SENNOSIDES 8.6mg in 1
INACTIVE INGREDIENT(S):
- CELLULOSE, MICROCRYSTALLINE
- STARCH, CORN
- SODIUM LAURYL SULFATE
- STEARIC ACID
- SODIUM BENZOATE
- CARNAUBA WAX
- D&C YELLOW NO. 10
- TITANIUM DIOXIDE
- TRIACETIN
- FD&C YELLOW NO. 6
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- CROSCARMELLOSE SODIUM
- FD&C YELLOW NO. 5
- MAGNESIUM SILICATE
- MAGNESIUM STEARATE
- HYPROMELLOSES
- MINERAL OIL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE

INGREDIENTS AND APPEARANCE

SENNA PLUS
sennosides and docusate sodium tablet

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

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70518-2462-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/02/2019

Labeler - REMEDYREPACK INC. (829572556)

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