Label: GERICARE DOCUSATE SODIUM LIQUID- docusate sodium liquid
- NDC Code(s): 57896-423-16
- Packager: GERI-CARE PHARMACEUTICALS, CORP
- 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 March 2, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not use for more than one week unless directed by a doctor.
Ask a doctore before use if you
- have stomach pain, nausea or vomiting
- hadve sudden change in bowel habits that persits over a period of 2 weeks
- are taking mineral oil
Stop use and ask doctor if
- you have rectal bleeding or fail to have a bowel movement afrer use of this product. 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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DOSAGE & ADMINISTRATION
Directions
shake well before using
- follow dosing directions below or use as directed by a physician
- do not exceed recommended dose
- must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
- may be taken as a single daily dose or in dividend dose
- take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
1 teasponnful = 5 mL
Age Dose Adults and children over 12 years of age 1 to 6 teaspoons (5 mL - 30 mL) Children under 12 years of age Ask a doctor -
OTHER INFORMATION
- each teaspoonful (5 mL) contains: sodium 9 mg
- store at room temperature 15°- 30° (59°-86°F)
- protect from excessive heat
- Pharmacist-Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP
- Tamper-Evident: Do not use if foil over bottle opening is torn, broken, or missing
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GERICARE DOCUSATE SODIUM LIQUID
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-423 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 FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 124 (UNII: 1S66E28KXA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-423-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/01/2023 Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)