Buprenorphine and Naloxone Sublingual Film (Buprenorphine and Naloxone) 4 mg / 1 mg

FILMSUBLINGUALAlvogen Inc.NDC: 47781-356Updated: Mar 2026

Active Ingredients

BUPRENORPHINE HYDROCHLORIDE — 4 mg

NALOXONE HYDROCHLORIDE DIHYDRATE — 1 mg

Inactive Ingredients (Fillers)

⚠️ 3 ingredients flagged as common allergens

Alcohol

⚠️ Yes — Alcohol

Solvent/Preservative

FD&C Yellow No. 6

⚠️ Yes — Dye

Colorant

Propylene Glycol

⚠️ Yes — Propylene Glycol

Solvent/Humectant

Acesulfame Potassium

Sweetener

Ammonia Solution

pH Adjuster

Butyl Alcohol

Solvent

Citric Acid Monohydrate

pH Adjuster/Buffer

Isopropyl Alcohol

Solvent/Antiseptic

Maltitol

Polyethylene Oxide 100000

Polyethylene Oxide 200000

Polyethylene Oxide 900000

Potassium Hydroxide

pH Adjuster

Titanium Dioxide

Colorant/Opacifier

Trisodium Citrate Dihydrate

Buffer

Ingredient	Purpose	Common Allergen?	Description
Alcohol	Solvent/Preservative	⚠️ Yes — Alcohol	Ethanol (ethyl alcohol) used as a solvent, preservative, or extraction agent. Present in many liquid formulations. May be relevant for patients avoiding alcohol for medical or religious reasons.
FD&C Yellow No. 6	Colorant	⚠️ Yes — Dye	An artificial colorant (also called Sunset Yellow). May cause reactions in people sensitive to artificial dyes.
Propylene Glycol	Solvent/Humectant	⚠️ Yes — Propylene Glycol	An organic compound used as a solvent and humectant. Can cause contact dermatitis in sensitive individuals.
Acesulfame Potassium	Sweetener	No	A non-caloric artificial sweetener (Ace-K) approximately 200 times sweeter than sugar. Used to improve taste in oral medications.
Ammonia Solution	pH Adjuster	No	Dilute ammonia used to adjust pH in pharmaceutical formulations. Present in trace amounts in the final product.
Butyl Alcohol	Solvent	No	Also known as n-butanol. Used as a solvent in pharmaceutical coatings and formulations.
Citric Acid Monohydrate	pH Adjuster/Buffer	No	Citric acid in its hydrated form. Used to adjust acidity and as a buffering agent. Derived from citrus fruits or fermentation.
Isopropyl Alcohol	Solvent/Antiseptic	No	Rubbing alcohol. Used as a solvent in topical formulations and as an antiseptic agent.
Maltitol	—	No	—
Polyethylene Oxide 100000	—	No	—
Polyethylene Oxide 200000	—	No	—
Polyethylene Oxide 900000	—	No	—
Potassium Hydroxide	pH Adjuster	No	A strong alkali used to adjust pH in pharmaceutical formulations. Present only in trace amounts in the final product.
Titanium Dioxide	Colorant/Opacifier	No	A white pigment used for coating opacity. Under regulatory review in some countries.
Trisodium Citrate Dihydrate	Buffer	No	Sodium citrate. Used as a buffering agent to maintain pH stability in liquid and injectable formulations.