SENNA-PLUS- sennosides and docusate sodium tablet

SENNA-PLUS by

Drug Labeling and Warnings

SENNA-PLUS by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 one 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 two 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 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.

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 3 mg
• store at controlled room temperature
  Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
• product of India

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Package Label

INGREDIENTS AND APPEARANCE

SENNA-PLUS 
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-555
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	BSD22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-555-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019
2	NDC: 57896-555-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019
3	NDC: 57896-555-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019
4	NDC: 57896-555-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/01/2019

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)