Sodium Fluoride Chewable Tablet
Product Images NDC 71335-2724

The product is a chewable tablet containing 2.2 mg of Sodium Fluoride, providing 1.0 mg of fluoride for children aged 6-16 in areas with low fluoride levels in drinking water. The tablet is white to off-white with an orange flavor, round in shape, and embossed with "M162". It is recommended to dissolve or chew the tablet before swallowing, preferably at bedtime after brushing teeth. Caution is advised not to consume dairy products within one hour of administration. It is essential to keep the medication out of reach of children, and in case of accidental overdose, seek immediate assistance. The tablet must be dispensed in a secure container with a child-resistant closure. Any prescription substitutions should adhere to state regulations. This product is not listed in the Orange Book. Side effects should be reported to Method Pharmaceuticals, LLC or the FDA, and medical advice should be sought from a doctor.*

The text describes a package insert for chewable tablets containing 1.0 mg of Fluoride ion derived from 2.2 mg of Sodium Fluoride. The tablets are sugar and dye-free and contain inactive ingredients such as magnesium stearate, malic acid, microcrystalline cellulose, orange flavor, sucralose, talc, and xylitol. The dosage and administration instructions suggest scanning the package for more information, with a QR code available for dosage and prescribing information. The tablets should be stored in a cool, dry place at room temperature between 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F). Storage in the original container is recommended. The tablets come in a package of 120 and have been relabeled by Bryant Ranch Prepack, Inc. and manufactured by Method Pharmaceutical LLC in Burbank, CA.*