Buprenorphine and Naloxone (buprenorphine and naloxone) 12 mg / 3 mg

FILMSUBLINGUALINGENUS PHARMACEUTICALS, LLCNDC: 50742-365Updated: Mar 2026

Active Ingredients

BUPRENORPHINE HYDROCHLORIDE — 12 mg

NALOXONE HYDROCHLORIDE — 3 mg

Inactive Ingredients (Fillers)

⚠️ 4 ingredients flagged as common allergens

FD&C Blue No. 1

⚠️ Yes — Dye

Colorant

FD&C Yellow No. 6

⚠️ Yes — Dye

Colorant

Povidone K30

⚠️ Yes — Povidone

Binder

Sodium Metabisulfite

⚠️ Yes — Sulfite

Antioxidant/Preservative

Acesulfame Potassium

Sweetener

Ammonia Solution

pH Adjuster

Anhydrous Citric Acid

pH Adjuster/Buffer

Butylated Hydroxyanisole

Antioxidant

Disodium Citrate Sesquihydrate?

Buffer

Maltitol

Polyethylene Oxide 1000000

Polyethylene Oxide 2000000

Polyethylene Oxide 900000

Shellac

Coating Agent

Ingredient	Purpose	Common Allergen?	Description
FD&C Blue No. 1	Colorant	⚠️ Yes — Dye	A synthetic blue dye. Less commonly allergenic than other dyes but reactions are documented.
FD&C Yellow No. 6	Colorant	⚠️ Yes — Dye	An artificial colorant (also called Sunset Yellow). May cause reactions in people sensitive to artificial dyes.
Povidone K30	Binder	⚠️ Yes — Povidone	A grade of polyvinylpyrrolidone (PVP) used as a binder in tablet manufacturing. The K30 denotes a specific molecular weight range.
Sodium Metabisulfite	Antioxidant/Preservative	⚠️ Yes — Sulfite	A sulfite compound used as an antioxidant and preservative. Can trigger severe reactions (bronchospasm, anaphylaxis) in sulfite-sensitive individuals, particularly asthmatics.
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.
Anhydrous Citric Acid	pH Adjuster/Buffer	No	Water-free citric acid used to adjust pH and enhance drug stability. Typically derived from fermentation of corn sugar.
Butylated Hydroxyanisole	Antioxidant	No	BHA. A synthetic antioxidant used to prevent rancidity of fats and oils. Rare contact sensitivity reported.
Disodium Citrate Sesquihydrate?	Buffer	No	A sodium salt of citric acid used as a buffering agent to maintain pH stability in pharmaceutical solutions.
Maltitol	—	No	—
Polyethylene Oxide 1000000	—	No	—
Polyethylene Oxide 2000000	—	No	—
Polyethylene Oxide 900000	—	No	—
Shellac	Coating Agent	No	A natural resin secreted by the lac insect. Used as an enteric coating for tablets and as a glazing agent. Derived from insects — relevant for vegan, vegetarian, and some religious dietary considerations.