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

FILMSUBLINGUALMylan Pharmaceuticals Inc.NDC: 0378-8768Updated: Mar 2026

Active Ingredients

BUPRENORPHINE HYDROCHLORIDE — 12 mg

NALOXONE HYDROCHLORIDE DIHYDRATE — 3 mg

Inactive Ingredients (Fillers)

⚠️ 1 ingredient flagged as common allergen

FD&C Yellow No. 6

⚠️ Yes — Dye

Colorant

Acesulfame Potassium

Sweetener

Anhydrous Citric Acid

pH Adjuster/Buffer

Hypromellose 2910 (15 Mpa.s)

Coating/Thickener

Maltitol

Polyethylene Glycol 8000

Coating/Binder

Polyethylene Oxide 200000

Polyethylene Oxide 900000

Titanium Dioxide

Colorant/Opacifier

Trisodium Citrate Dihydrate

Buffer

Ingredient	Purpose	Common Allergen?	Description
FD&C Yellow No. 6	Colorant	⚠️ Yes — Dye	An artificial colorant (also called Sunset Yellow). May cause reactions in people sensitive to artificial dyes.
Acesulfame Potassium	Sweetener	No	A non-caloric artificial sweetener (Ace-K) approximately 200 times sweeter than sugar. Used to improve taste in oral medications.
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.
Hypromellose 2910 (15 Mpa.s)	Coating/Thickener	No	A higher-viscosity grade of hydroxypropyl methylcellulose used for sustained-release coatings and thickening. Plant-derived.
Maltitol	—	No	—
Polyethylene Glycol 8000	Coating/Binder	No	A high-molecular-weight PEG used in tablet coatings and as a binder. Rare PEG allergies have been documented.
Polyethylene Oxide 200000	—	No	—
Polyethylene Oxide 900000	—	No	—
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.

Exclusion Groups

This medication contains ingredients flagged in the following groups. Patients with these sensitivities should consult their prescriber.

🌾Gluten 🔴Alpha-Gal Syndrome 🎨Dyes & Colorants 🍬Polyols (GI)🌱Not Vegan ☪️Halal Concern ✡️Kosher Concern 🥦Not Vegetarian

AllergenMaps

Ingredient

Purpose

Common Allergen?