Label: DOCUSATE SODIUM liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-6209-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 50383-771
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 3, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each teaspoon)
- Purpose
- Uses
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Warnings
Do not use
- if you are presently taking mineral oil
- when abdominal pain, nausea, or vomiting are present
- for longer than one week
Ask a doctor before use if you have
noticed a sudden change in bowel habits that lasts over two weeks.
Ask a doctor or pharmacist before use 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
DOCU LIQUID
(Docusate Sodium 50 mg/5 mL)
NDC 54868-6209-0
NET CONTENTS ONE PINT (473 mL)
STOOL SOFTENER LAXATIVE
TAMPER EVIDENT: FOR YOUR PROTECTION, THIS BOTTLE HAS A SAFETY SEAL AROUND THE NECK OR UNDER THE CAP.Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Additional bar code labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6209(NDC:50383-771) 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 in 5 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) VANILLA (UNII: Q74T35078H) WATER (UNII: 059QF0KO0R) POLOXAMER 181 (UNII: 09Y8E6164A) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6209-0 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/07/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel