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.)

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.

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

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 – 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. SeeCONTRAINDICATIONS.