Docusate Sodium with Sennosides by PD-Rx Pharmaceuticals, Inc.

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]

DOCUSATE SODIUM WITH SENNOSIDES- docusate sodium -sennosides tablet, coated 
PD-Rx Pharmaceuticals, Inc.

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.

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Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

relieves occasional constipation

generally produces bowel movement in 6-12 hours.

ASK A DOCTOR BEFORE USE IF YOU HAVE A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER TWO WEEKS

Ask a doctor or pharmacist if you are taking any other drug.  Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Do not use if your are taking mineral oil; for longer than one week; when abdominal pain, nausea or vomiting are present

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

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

call 1 800 645-2158

Stop use and ask a doctor if: you fail to have a bowel movement after use of this product. you have rectal bleeding; These may indicate a serious condition.

  Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium

D-C yellow #10 aluminum lake, dibasic calcium phosphate

dihydrate, FD-C yellow #6 aluminum lake, hypromellose,

magnesium stearate, microcrystalline cellulose, polyethylene

glycol, sodium benzoate, stearic acide, Titanium dioxide

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage- 1 tablet twice a day

children uner 2 years - ask a doctor

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

HOW SUPPLIED

Docusate sodium 50 mg and Sennosides 8.6 mg

The 50 mg/8.6 mg tablets are supplied as orange round shaped tablets debossed “TCL081” on one side and plain on other side.

Bottles of 28 tablets.

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

DOCUSATE SODIUM WITH SENNOSIDES 
docusate sodium -sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43063-818(NDC: 0536-4086)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-818-28	28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/2017	01/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/21/2017	01/09/2020

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(43063-818)

Revised: 1/2020

Document Id: 9bb8b49b-b943-7a6f-e053-2995a90a1298

34390-5

Set id: f12c6344-c59b-4b76-8b49-f971d7f08f14

Version: 7

Effective Time: 20200109