Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Opium Tincture, USP (Deodorized), is supplied as: NDC 62559-153-04 Bottles of 4 fl oz Dispense in tightly closed containers. Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP). Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9424 Rev 01/25 ani; Package/Label Display Panel Opium Tincture USP (Deodorized), 10 mg/mL of anhydrous morphine, CII NDC 62559-153-04 Rx only 118 mL (4 fl. oz.) Label
- HOW SUPPLIED Opium Tincture, USP (Deodorized), is supplied as: NDC 62559-153-04 Bottles of 4 fl oz Dispense in tightly closed containers. Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP). Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9424 Rev 01/25 ani
- Package/Label Display Panel Opium Tincture USP (Deodorized), 10 mg/mL of anhydrous morphine, CII NDC 62559-153-04 Rx only 118 mL (4 fl. oz.) Label
Overview
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.
Indications & Usage
Opium tincture is useful for the treatment of diarrhea.
Dosage & Administration
Usual Adult Dose – 0.6 mL orally 4 times a day.
Warnings & Precautions
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.
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.
Adverse Reactions
Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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