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 Rij Pharmaceutical Corporation. 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 (Per Teaspoonful = 5 Ml)
Docusate Sodium 50 mg
Purpose
Stool Softener
Uses
- prevents / relieves dry hard stool
- results usually occur 1 to 3 days after the first dose
Warnings
Do not use
- when abdominal pain, nausea, or vomiting are present
- 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 lasts more than 2 weeks Stop use and ask a doctor if
- 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.
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
- 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
| 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
Inactive Ingredients
citric acid, D&C Red #33, flavor, parabens, poloxamer, propylene glycol, sodium citrate, sorbitol, sucrose, and water.
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