Docusate Sodium Liquid
FDA Label NDC 55154-2346

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Docusate Sodium (NDC 55154-2346). 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

Other

Drug Facts

R06/22

Distributed by:

MAJOR® PHARMACEUTICALS 

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458961223

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:

    • Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-2346-5

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

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

Bag Label (Ee14dfe2 405f 493a A774 Ce1b01d05dd4 00)

Bag Label (Ee14dfe2 405f 493a A774 Ce1b01d05dd4 00)

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