Active Ingredient (In Each 5 Ml Teaspoonful)
Docusate Sodium 50 mg
Stool Softener Liquid
FDA Label NDC 17856-0398
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Stool Softener Liquid (NDC 17856-0398). 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, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, 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
Do not use for more than one week unless directed by a doctor
Ask a doctor before use if you
- have abdominal pain, nausea, or vomiting
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts more than 14 days
- you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.
- a skin rash occurs
- you experience throat irritation
Stop use and ask a doctor if
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 overdose, get medical help or contact a poison control Center right away.
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 daily dose until first bowel movement, then reduce dose according to individual response
- shake well before using
| Adults and children 12 years and over
| 1 to 4 teaspoonfuls (5 to 20 mL)
|
| Children under 12 years of age
| ask a doctor |
Other Information
- Each teaspoonful contains: sodium 15 mg
- Store at room temperature 15°- 30° C (59°-86° F)
- protect from excessive heat
- Keep tightly closed
Inactive Ingredients
citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
20101 N.E 16TH PLACE
MIAMI, FL 33179
Package Label
NDC 17856-0398-1
Compare to Colace® Liquid active ingredient *
GOOD NEIGHBOR PHARMACY
STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
250mg/25 mL
50 cups per case
Image 1 (17856 0398 01)
NDC 17856-0398-2
Compare to Colace® Liquid active ingredient *
GOOD NEIGHBOR PHARMACY
STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
100mg/10 mL
72 cups per case
Image 2 (17856 0398 02)
* Please review the disclaimer below.
