Opium
Opium is an FDA drug label for the active ingredient MORPHINE manufactured by Genus Lifesciences 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 20260507.
- Generic name
- MORPHINE
- Manufacturer
- Genus Lifesciences Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 64950-258
- Application
- N/A
- Label effective
- 20260507
About this product
Opium is an FDA-registered drug product whose active ingredient is MORPHINE. It is labelled by Genus Lifesciences Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 64950-258, label effective 20260507. 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 MORPHINE are most often described in connection with: usage opium, tincture useful, treatment diarrhea. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Indications & Usage
INDICATIONS AND USAGE Opium tincture is useful for the treatment of diarrhea.
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Adult Dose – 0.6 mL orally 4 times a day.
Contraindications
CONTRAINDICATIONS This preparation is not recommended for use in children. It should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.
Warnings
WARNINGS Addiction can result from opium usage. Opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.
Adverse Reactions
ADVERSE REACTIONS Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.
Recall and safety notices
5 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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0231-2021 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups) | Genus Lifesciences Inc. | Class III | Terminated | 20210120 |
| D-0471-2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53 | Cipla USA, Inc. | Class II | Terminated | 20240501 |
| D-0197-2024 | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41 | CARDINAL HEALTHCARE | Class II | Terminated | 20240103 |
| D-0161-2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64 | CARDINAL HEALTHCARE | Class II | Terminated | 20240103 |
| D-0080-2024 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01 | Edenbridge Pharmaceuticals, LLC | Class III | Terminated | 20231108 |
Frequently asked questions
What is Opium used for?
INDICATIONS AND USAGE Opium tincture is useful for the treatment of diarrhea.
Who makes Opium?
Genus Lifesciences Inc. is the labeler of record for Opium.
What form does Opium 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 Opium prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Opium been recalled?
5 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.