DOCUSATE SODIUM WITH SENNOSIDES- docusate sodium 50mg and sennosides 8.6mg tablet, film coated

Docusate Sodium With Sennosides by

Drug Labeling and Warnings

Docusate Sodium With Sennosides by is a Otc medication manufactured, distributed, or labeled by PD-Rx 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 right away.(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 daily	4 tablets twice daily
Children 6 to under 12 years	1 tablet once daily	2 tablets  twice daily
Children 2 to under 6 years	1/2 tablet  once daily	1 tablet twice daily
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 15 o-30 oC (59 o-86 oF)

Inactive ingredients

crosscarmellose 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?

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

16 HOW SUPPLIED/STORAGE AND HANDLING

Docusate Sodium with Sennosides is a orange, round tablet; Debossed with PH32.

Bottles of 100 NDC: 43063-958-01

Bottles of 1000 NDC: 43063-958-95

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

PRINCIPAL DISPLAY PANEL

NDC: 43063-958-01

Manufactured in the USA

*Compare to the active ingredients in Senokot-S ®

Docusate Sodium 50mg &

Sennosides 8.6mg

Natural Vegetable Laxative

Ingredient Plus Stool Softner

100 TABLETS

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM WITH SENNOSIDES 
docusate sodium 50mg and sennosides 8.6mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43063-958(NDC:16103-378)
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 (ORANGE COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-958-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2019
2	NDC: 43063-958-95	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/05/2018

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(43063-958)