Active Ingredient (In Each 5 Ml-Teaspoonful)
Docusate Sodium 50mg
Curewell Docusate Sodium Liquid Solution
FDA Label NDC 85111-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rmt Health Llc for the product Curewell Docusate Sodium Liquid (NDC 85111-403). 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 Laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours
Warnings
- for more than one week unless directed by a doctor
Do Not Use
- for more than one week unless directed by a doctor
Ask A Doctor Before Use If You
• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil
Stop Use And Ask A Doctor If
• you have rectal bleeding or fail to have a bowel movement after use of this product. These could be signs of a serious 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 right away.
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 6oz to 8oz glass of milk or fruit juice to prevent throat irritation
• may be taken as a single dose or in divided doses
take maximum dose daily until first bowel movement, dosage should then be reduces according to individual response.
AGE | DOSE |
| Adults and Children 12 years of age and over | 1 to 6 teaspoonsfuls (5ml-30mL) |
| Children under 12 years of age | Ask a doctor |
Other Information
- each teaspoon (5ml) contains: sodium 9 mg
- store at room temperature 15-30°C (59-86°F)
- protect from excessive heat
- Pharmacist-Preserve and dispense in a tight, light-resistant container with a child-resistant cap as defined in the UPS
- TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
Inactive Ingredient
FD&C red#40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate and sucralose
Question Or Comments?
1-800-540-3765
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