Docusate Sodium DOCUSATE SODIUM PAI HOLDINGS, LLC DBA PAI PHARMA FDA Approved Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Docusate sodium 50 mg
Inactive Ingredients
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.
Strengths
5 ml 50 mg
Quantities
473 ml 5 ml 10 ml
Treats Conditions
Uses Relieves Occasional Constipation Irregularity Generally Produces Bowel Movement In 12 To 72 Hours
Pill Appearance
Color: pink

Identifiers & Packaging

Container Type BOTTLE
UNII
F05Q2T2JA0
Packaging

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML) NDC 0121-0935-16 Docusate Sodium Liquid 50 mg/5 m L STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 X0935160721 R07/21 16 fl oz (473 mL) bottle label; PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding NDC 0121-0935-05 Docusate Sodium Liquid 50 mg/5 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 5 mL unit dose cup; PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding NDC 0121-1870-10 Docusate Sodium Liquid 100 mg/10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 10 mL unit dose cup

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML) NDC 0121-0935-16 Docusate Sodium Liquid 50 mg/5 m L STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 X0935160721 R07/21 16 fl oz (473 mL) bottle label
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding NDC 0121-0935-05 Docusate Sodium Liquid 50 mg/5 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 5 mL unit dose cup
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding NDC 0121-1870-10 Docusate Sodium Liquid 100 mg/10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 10 mL unit dose cup

Overview

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Indications & Usage

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage & Administration

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

Warnings & Precautions
Warnings 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Stool softener

Do Not Use

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Stop Use & Ask a Doctor

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

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.

Storage & Handling

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.

Questions

Questions or comments? Call 1-800-845-8210


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