Label: DOCUSATE SODIUM LIQUID- docusate sodium liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-216-08, 53807-216-16 - Packager: Rij Pharmaceutical Corporation
- 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 April 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (per teaspoonful = 5 mL)
- Purpose
- Uses
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Warnings
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts more than 2 weeks
- you have no bowel movement within 3 days
- you have rectal bleeding
- these could be signs of a serious condition
- a skin rash occurs
- you experience throat irritation
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- follow dosing directions below or take as directed by doctor
- must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
- may be taken as a single daily dose or in divided doses
- take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
- do not exceed recommended dose
- shake well before using
Adults and children 12 years and over
1 to 4 teaspoons (50 to 200 mg)
Children under 12 years of age
ask a doctor
1 teaspoon = 5 mL
TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
Other information
- Store at room temperature 15°-30°C (59°-86°F)
- protect from excessive heat
- Keep tightly closed
- Dispense in tight, light resistant container as defined in the USP
- each teaspoon (5 mL) contains: sodium 15 mg
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM LIQUID
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-216 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) D&C red no. 33 (UNII: 9DBA0SBB0L) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) propylene glycol (UNII: 6DC9Q167V3) sodium citrate (UNII: 1Q73Q2JULR) water (UNII: 059QF0KO0R) Poloxamer 407 (UNII: TUF2IVW3M2) SUCROSE (UNII: C151H8M554) SORBITOL (UNII: 506T60A25R) Product Characteristics Color PINK Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-216-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/16/1999 2 NDC:53807-216-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-216)
