SENNA PLUS- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Senna Plus by

Drug Labeling and Warnings

Senna Plus by is a Otc medication manufactured, distributed, or labeled by SDA Laboratories, Inc., Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

Laxative

Stool softner

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor
• if you are taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.

If pregnant or breast feeding,

ask a healthcare professional before use. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
Adults and children 12 years and over	2 tablets once a day	4 tablets twice a day
Children 6 to under 12 years	1 tablet once a day	2 tablets  twice a day
Children 2 to under 6 years	1/2 tablet  once a day	1 tablet twice a day
Children under 2 years	ask a doctor	ask a  doctor

Other information

• each tablet contains 10 mg of calcium, sodium 5 mg
• store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)
• Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

Questions or comments?

(800) 687-0176 Mon-Fri 8 AM to 4 PM EST

PRINCIPAL DISPLAY PANEL

NDC: 66424-378-02

*Compare to the active ingredients in Senokot-S®

Senna Plus

Natural Vegetable laxative

Ingredient Plus Stool Softener

SENNOSIDES 8.6 mg &

DOCUSATE SODIUM 50mg

SDA LABORATORIES

20 Tablets Free!!

120 Tablets

INGREDIENTS AND APPEARANCE

SENNA PLUS 
sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66424-378
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66424-378-02	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/15/2019

Labeler - SDA Laboratories, Inc. (948067889)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(66424-378) , analysis(66424-378) , pack(66424-378) , label(66424-378)