Drug Facts
Composition & Profile
Identifiers & Packaging
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; 118 mL image description image description; 473mL image description image description
- 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
- 118 mL image description image description
- 473mL image description image description
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.