Morphine is a prescription medicine (Opioid Agonist). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- Opium, Opium Tincture Deodorized
- Drug class
- Opioid Agonist
- Taken
- Oral
- Label
- Genus Lifesciences Inc., revised May 7, 2026 · full label on DailyMed
- Generic
- FDA-approved (15 companies) · details
What it is used for
Opium tincture is useful for the treatment of diarrhea.
Who should not take it (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
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.
Precautions
General Opium should be used with caution in the elderly, in debilitated individuals, and in patients with increased intracranial pressure, cerebral arteriosclerosis, hepatic cirrhosis or liver insufficiency, gastrointestinal hemorrhage, myxedema, emphysema, and bronchial asthma. Drug Interactions When preparations containing opium are administered in combination with other drugs, the cautions applicable to each ingredient should be borne in mind. Reduced dosage is indicated in poor-risk patients, in the very young or very old patient, and in those who are receiving other central-nervous system depressants. Usage in Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Opium Tincture, USP (Deodorized). It is also not known whether Opium Tincture, USP (Deodorized), can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Opium Tincture, USP (Deodorized), should be given to a pregnant woman only if clearly needed. Nursing Mothers Caution should be exercised when Opium Tincture, USP (Deodorized), is administered to a nursing woman. Usage in Children Safety and effectiveness in children have not been established. See Contraindications .
Side effects (adverse reactions)
Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.
Drug interactions
When preparations containing opium are administered in combination with other drugs, the cautions applicable to each ingredient should be borne in mind. Reduced dosage is indicated in poor-risk patients, in the very young or very old patient, and in those who are receiving other central-nervous system depressants.
Pregnancy
Usage in Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Opium Tincture, USP (Deodorized). It is also not known whether Opium Tincture, USP (Deodorized), can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Opium Tincture, USP (Deodorized), should be given to a pregnant woman only if clearly needed.
Breastfeeding
Caution should be exercised when Opium Tincture, USP (Deodorized), is administered to a nursing woman.
Is there a generic Morphine?
Yes. The FDA has approved generic Morphine from 15 companies whose approvals are active. The earliest of these was approved in 1992.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Actavis Elizabeth, Alkem Labs Ltd, Dava Pharms Inc, Hikma, Hospira, Intl Medication Sys, Pharm Assoc, Piramal Critical, Quagen, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Ltd, Tris Pharma Inc, Upsher Smith Labs, Winder Labs Llc
Brand-name versions
- Infumorph Hikma, approved 1984
- Ms Contin Knoa Pharma, approved 1987
- Morphine Sulfate (autoinjector) Meridian Medcl Techn, approved 1990 Discontinued
- Oramorph Sr Xanodyne Pharms Inc, approved 1991 Discontinued
- Kadian Allergan, approved 1996 Discontinued
- Avinza King Pharms Llc, approved 2002 Discontinued
- Depodur Pacira Pharms Inc, approved 2004 Discontinued
- Morphabond Er Ohemo Life, approved 2015 Discontinued
- Arymo Er Zyla, approved 2017 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Morphine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class III Terminated
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
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
- Distribution
- Nationwide within the United States
- Quantity
- 4548 bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0080-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Morphine
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 8a77894b-2137-4f46-8dff-5c7b773d4d16.