FDA Label for Docusate Sodium Liquid
View Indications, Usage & Precautions
Docusate Sodium Liquid Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. 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.
Otc - Active Ingredient
Active Ingredients (per 5 mL)
Docusate Sodium 50 mg
Otc - Purpose
Purpose
Stool Softener
Indications & Usage
Uses
Relief of occasional constipation
Warnings
Warnings
Do not use when
- abdominal pain, nausea, or vomiting are present unless directed by a doctor
- for more than one week unless directed by a doctor
- are taking mineral oil
- have noticed a sudden change in bowel habits that last more than two weeks
- you have no bowel movements within 3 days
- you have rectal bleeding
- these could be signs of a serious condition
- a skin rash occurs
- you experience throat irritation
Ask a doctore before use if you
Stop use and ask doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.
Dosage & Administration
Directions
- follow dosing directions below or use as directed by a physician
- 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
- do not exceed recommended dose
- shake well before using
1 teasponnful = 5 mL
Age | Dose |
Adults and children over 12 years of age | 1 to 6 teaspoons (50 mg - 300 mg) |
Children under 12 years of age | Ask a doctor |
Inactive Ingredient
Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose
DISTRIBUTED BY
ATLANTIC BIOLOGICALS CORP
MIAMI, FL 33179
Otc - Questions
Questions or comments? 1-800-645-2158
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