SENNA PLUS- sennosides and docusate sodium tablet
NORTHEAST PHARMA

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.

----------

HPC 455t

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 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 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, D&C yellow #10 lake, FD&C yellow #6 lake,
hypromellose, magnesium stearate, PEG, silica, sodium benzoate,
stearic acid, titanium dioxide, wax.

Package Label

SENNA PLUS
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80136-455
Route of Administration	ORAL

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 STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80136-455-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/2020	06/30/2023

Labeler - NORTHEAST PHARMA (081232935)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2022

Document Id: ee12bfa3-4914-7b6a-e053-2995a90ae1a4

Set id: b5e3ad66-b774-1023-e053-2995a90a6564

Version: 3

Effective Time: 20221122

NORTHEAST PHARMA