Senna Plus: Package Insert and Label Information

SENNA PLUS- sennosides and docusate sodium tablet, film coated
CARDINAL HEALTH, 110 DBA LEADER

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.

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool Softener

Laxative

Uses

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

Warnings

Do not use

• if you are taking mineral oil, unless directed by a doctor
• laxative products for longer than 1 week 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 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 (1-800-222-1222).

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: calcium 10 mg, sodium 5 mg, Very Low Sodium
• store at 20-25°C(68-77°F); excursions permitted between 15^o -30^o C (59^o -86^o F)

Inactive ingredients

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

Questions or comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

LEADER _TM

NDC 70000-0520-1

Senna Plus

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

Stool Softener l Laxative

Dual Action

Standardized

Senna Concentrate

COMPARE TO

SENOKOT-S^®

active ingredients*

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30 TABLETS

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0520 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM BENZOATE TALC TITANIUM DIOXIDE

Product Characteristics Color orange (ORANGE COLOR) Score no score Shape ROUND (ROUND TABLET) Size 10mm Flavor Imprint Code PH32 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70000-0520-1 30 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (70000-0520-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/23/2019

Labeler — CARDINAL HEALTH, 110 DBA LEADER (063997360)

Registrant — Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture (70000-0520), analysis (70000-0520), pack (70000-0520), label (70000-0520)

Revised: 06/2021 CARDINAL HEALTH, 110 DBA LEADER