Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 55154-0578

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 55154-0578). 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 softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Softgel)

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Other

→ Principal Display Panel

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours.

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
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product. These can be signs of a serious condition
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• take only by mouth • take softgels with a full glass (8 oz) of water

adults and children 12 years of age and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of age	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other Information

• each softgel contains: sodium 5 mg (very low sodium)
• store at controlled room temperature 20–25°C (68–77°F)
• protect from light, heat and moisture

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1(888) 577-8033

Other

Distributed by:
MAJOR^® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471

Overbagged with 10 softgels per bag, NDC 55154-0578-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L61399840626

www.major-rugby.com
Made in India
CT0904760961
REV.00-092025

Rev. 10/25 M-173 Re-order No. 701455

READ AND KEEP OUTER CARTON FOR COMPLETE
PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.