Active Ingredient (In Each 5 Ml-Teaspoonful)
Docusate Sodium 50mg
Docusate Sodium Liquid Solution
FDA Label NDC 73564-813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldama Pharmaceuticals, Inc for the product Docusate Sodium Liquid (NDC 73564-813). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml-teaspoonful), purpose, uses, warnings, do not use, ask a doctor before use if you, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Uses
- Relief of occasional constipation
Warnings
- abdominal pain, nauseas, or vomiting are present unless directed by a doctor
- for more than one week unless directed by a doctor
Do Not Use
- abdominal pain, nauseas, or vomiting are present unless directed by a doctor
- for more than one week unless directed by a doctor
Ask A Doctor Before Use If You
- are taking mineral oil
- have noticed a sudden change in bowel habits that last more than two weeks
Stop Use And Ask A Doctor If
- you have no bowel movements withing 3 days
- you have rectal bleeding
- these could be signs of a seriuos condition
- a skin rash occurs
- you experience throat irritation
If Pregnant Or Breast-Feeding
ask a doctor before use
Keep Out Of Reach Of Children.
In case of overdose, seek medical assistance or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- follow dosing directions below or use as directed by a physician
- must be give in a 6 oz to 8 oz glass of mil 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 the be reduced according to individual response
- do not exceed recommende dose
- shake well before using
Other Information
- TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
- store at room temperature between 20-25°C (68-77°F)
- Permitted excursions between 15-30°C (59-86°F)
- protect from excessive heat
- Pharmacist:: preserve and dispense in a tight light, light-resistant container with a child-resistant cap as defined in the UPS
- each teaspoon (5ml) contains sodium 5 mg
Inactive Ingredient
artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Question Or Comments?
305-592-9216 or [email protected]
* Please review the disclaimer below.
