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Drug Facts
MANUFACTURED BY
Pharmaceutical Associates, Inc.
Greenville, SC 29605
R12/20
Docusate Sodium Liquid
FDA Label NDC 0121-1870
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Docusate Sodium (NDC 0121-1870). 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 other, active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Docusate sodium 50 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do Not Use
- if you are presently taking mineral oil, unless told to do so by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a stool softener laxative for more than 1 week
- rash occurs
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
- Dose once daily
- take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
| adults and children 12 years and older | 5 to 20 mL (1 to 4 teaspoonfuls) |
| children 6 to under 12 years of age | 5 to 10 mL (1 to 2 teaspoonfuls) |
| children 3 to under 6 years of age | 2.5 to 5 mL (1/2 to 1 teaspoonful) |
| children under 3 years | ask a doctor |
Other Information
- • Sodium content: 14 mg/ 5 mL
• Store at controlled room temperature, 20° to 25°C (68° to 77°F)
• Protect from freezing
• Protect from light
• Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:
NDC 0121-0935-16: 16 fl oz (473 mL) bottle
NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients
artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.
Questions Or Comments?
Call 1-800-845-8210
Principal Display Panel - 16 Fl Oz (473 Ml)
NDC 0121-0935-16
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
16 fl oz (473 mL)
Pharmaceutical Associates, Inc.
Greenville, SC 29605
X0935160721 R07/21
Principal Display Panel (16 fl oz (473 mL))
Principal Display Panel - 5 Ml Cup Tray Label
NDC 0121-0935-05
Docusate Sodium Liquid
50 mg/5 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Reistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel (5 mL Cup Tray Label)
Principal Display Panel - 10 Ml Cup Tray Label
NDC 0121-1870-10
Docusate Sodium Liquid
100 mg/10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
Package Not Child-Reistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Principal Display Panel (10 mL Cup Tray Label)
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