Sennosides by PD-Rx Pharmaceuticals, Inc. SENNOSIDES tablet

Sennosides by

Drug Labeling and Warnings

Sennosides by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Stimulant Laxative

Uses

• relieve occasional constipation (irregularity)
• this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

• Laxative products for longer than 1 week unless directed by a doctor

ASK 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

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of overdose, get medical help or contact a Posion Control Center immediately.

Other information

• each tablet contains: calcium 4 mg, sodium 3 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

colloidal sillicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call 516-341-0666

8:30am-4:30pm ET. Mon-Fri

Directions

take preferably at bedtime or as directed by a doctor

do not exceed maximum dosage

age	starting dosage	maximum dosage
adults and children 12 years of age or older	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

HOW SUPPLIED

Sennosides are round light brown tablets and have a imprint of S5. They are available as follows:

• Bottles of 10: 72789-283-10
• Bottles of 30: 72789-283-30

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed, light-resistant container as defined in the USP.

Protect from light.

PRINCIPAL DISPLAY PANEL

Sennosides 8.6 mg

Natural Vegetable Laxative

*Compare to the Active Ingredient in SENOKOT®

INGREDIENTS AND APPEARANCE

SENNOSIDES 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72789-283(NDC:69618-064)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown (light)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72789-283-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/22/2022
2	NDC: 72789-283-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/01/2020

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(72789-283)