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].

image

DOCUSATE SODIUM WITH SENNOSIDES 
docusate sodium -sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43063-818(NDC: 0536-4086)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43063-818-2828 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/201701/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/21/201701/09/2020
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-818)

Revised: 1/2020