Opium Tincture Deodorized
Morphine · Solution · Oral
Uses
Opium tincture is useful for the treatment of diarrhea.
Dosage and administration
Usual Adult Dose – 0.6 mL orally 4 times a day.
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
Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.
Overdosage
Signs and Symptoms – Symptoms of toxicity are those of morphine and alcohol, such as nausea, vomiting, miosis, cool and clammy skin, respiratory and CNS depression, bradycardia, hypotension, and skeletal muscle flaccidity. Noncardiogenic pulmonary edema may develop after opioid overdose and monitoring of heart filling pressure may be helpful. Ethanol has been demonstrated to cause hypoglycemia in children or adults with limited glycogen stores. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur. Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR) . In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Initial management of opioid overdose should emphasize establishment of a secure airway and support of ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, blood glucose, etc. Naloxone antagonizes most effects of opioids. Protect the airway as naloxone may induce vomiting. Since naloxone has a shorter duration of action than opioids, repeated doses may be needed. In patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. This may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. This syndrome usually abates quickly as the effect of naloxone dissipates. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Since opium tincture can delay gastric emptying, evacuation of the stomach may be beneficial. Safeguard the patient’s airway when employing gastric emptying or charcoal. Monitor for and treat hypoglycemia. The use of forced diuresis, peritoneal dialysis, hemodialysis or charcoal hemoperfusion has not been established to be beneficial.
Description
Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by “denarcotization” with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution. Each 100 mL contains 1 g of anhydrous morphine (represents the equivalent of 10 g of Powdered Opium, USP), alcohol, 19%, and water. Opium has a very characteristic odor and a very bitter taste. The opiates are the most effective and prompt-acting nonspecific antidiarrheal agents.
How supplied
Opium Tincture, USP (Deodorized), is supplied as: NDC 42799-217-01 Bottles of 4 fl oz NDC 42799-217-02 Bottles of 16 fl oz Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP). Manufactured for: Edenbridge Pharmaceuticals, LLC DBA Dexcel Pharma USA Parsippany, NJ 07054 USA 877-381-3336 Rev. 09/2024 1000009908-00
Label text from the FDA structured product label by Edenbridge Pharmaceuticals, LLC (revised Dec 26, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Morphine in 3 products
Opium Tincture Deodorized NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 62559-153 | Morphine 1 g/100mL Solution | ANI Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER · DEA CII |
| 63629-1965 | Morphine 10 g/1000mL Solution | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 42799-217 | Morphine 10 mg/mL Tincture | Edenbridge Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CII |
Opium Tincture Deodorized recalls
- D-0080-2024 Nov 8, 2023 · Class III · Terminated
Subpotent Drug
Frequently asked questions
What is Opium Tincture Deodorized used for?
Opium tincture is useful for the treatment of diarrhea.
What are the side effects of Opium Tincture Deodorized?
Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed. See the full label for the complete list.
Who makes Opium Tincture Deodorized?
Opium Tincture Deodorized is listed by 3 labelers in the FDA NDC directory, including ANI Pharmaceuticals, Inc., Bryant Ranch Prepack, Edenbridge Pharmaceuticals, LLC.
Has Opium Tincture Deodorized been recalled?
The FDA enforcement database lists 1 recall for Opium Tincture Deodorized, most recently D-0080-2024 (class iii): Subpotent Drug