Docusate Sodium Liquid

DOCUSATE SODIUM.50MG/5ML ORAL HUMAN OTC DRUG

Docusate Sodium Liquid is an FDA drug label for the active ingredient DOCUSATE SODIUM.50MG/5ML manufactured by Aldama Pharmaceuticals, Inc administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260810.

Generic name
DOCUSATE SODIUM.50MG/5ML
Manufacturer
Aldama Pharmaceuticals, Inc
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
73564-813
Application
M007
Label effective
20260810

About this product

Docusate Sodium Liquid is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM.50MG/5ML. It is labelled by Aldama Pharmaceuticals, Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 73564-813, application M007, label effective 20260810. It is one of 2 FDA drug label records sharing the active ingredient DOCUSATE SODIUM.50MG/5ML. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DOCUSATE SODIUM.50MG/5ML are most often described in connection with: relief occasional. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each 5 mL-teaspoonful) Docusate Sodium 50mg

Indications & Usage

Uses Relief of occasional constipation

Dosage & Administration

Directions follow dosing directions below or use as directed by a physician must be give in a 6 oz to 8 oz glass of mil or fruit juice to prevent throat irritation may be taken as a single daily dose or in dividend dose take maximum dose daily until first bowel movement dosage should the be reduced according to individual response do not exceed recommende dose shake well before using

Warnings

Warnings abdominal pain, nauseas, or vomiting are present unless directed by a doctor for more than one week unless directed by a doctor

More products with the same ingredient

DOCUSATE SODIUM.50MG/5ML

Curewell Docusate Sodium Liquid

RMT HEALTH LLC View label

How products containing DOCUSATE SODIUM.50MG/5ML compare

FDA lists 2 drug label records with DOCUSATE SODIUM.50MG/5ML as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Aldama Pharmaceuticals, Inc 1
— — RMT HEALTH LLC 1
— — — —
— — — —
— — — —

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0025-2025 OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06. Akron Pharma, Inc. Class II Ongoing 20241030

Frequently asked questions

What is Docusate Sodium Liquid used for?
Uses Relief of occasional constipation

Who makes Docusate Sodium Liquid?
Aldama Pharmaceuticals, Inc is the labeler of record for Docusate Sodium Liquid. 2 FDA label records share the active ingredient DOCUSATE SODIUM.50MG/5ML, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Docusate Sodium Liquid come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Docusate Sodium Liquid prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DOCUSATE SODIUM.50MG/5ML?
Yes. 2 FDA drug label records list DOCUSATE SODIUM.50MG/5ML as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Docusate Sodium Liquid been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.