FDA Label for Docusate Sodium Liquid
View Indications, Usage & Precautions
- 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
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTION OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Docusate Sodium Liquid Product Label
The following document was submitted to the FDA by the labeler of this product Aldama Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml-Teaspoonful)
Docusate Sodium 50mg
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]
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