Metaxalone (Page 3 of 3)

OVERDOSAGE
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol.

Serotonin syndrome has been reported when metaxalone was used at doses higher than the recommended dose (see WARNINGS and ADVERSE REACTIONS).

When determining the LD ₅₀ in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD ₅₀ could be determined as the higher doses produced an emetic action in 15 to 30 minutes.

Treatment — Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.

DOSAGE AND ADMINISTRATION
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

HOW SUPPLIED
Metaxalone Tablets, USP 800 mg are available as pink, capsule shape scored tablet debossed with ‘SG’ on scored side and ‘323’ on the other.

NDC 50228-323-30: Bottles of 30 Tablets
NDC 50228-323-01: Bottles of 100 Tablets
NDC 50228-323-05: Bottles of 500 Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers.

Rx Only

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

Rev: 5/2021

PRINCIPAL DISPLAY PANEL

NDC 50228-323-30

Metaxalone Tablets, USP

800 mg

SEALED FOR YOUR PROTECTION

30 Tablets Rx only

Sciegen

Pharmaceuticals, Inc.

NDC 50228-323-01

Metaxalone Tablets, USP

800 mg

This container is not intended for household use.

SEALED FOR YOUR PROTECTION

100 Tablets Rx only

Sciegen

Pharmaceuticals, Inc.

NDC 50228-323-05

Metaxalone Tablets, USP

800 mg

This container is not intended for household use.

SEALED FOR YOUR PROTECTION

500 Tablets Rx only

Sciegen

Pharmaceuticals, Inc.

METAXALONE metaxalone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50228-323 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METAXALONE (METAXALONE) METAXALONE 800 mg

Inactive Ingredients Ingredient Name Strength ALGINIC ACID STARCH, CORN FERRIC OXIDE RED COPOVIDONE K25-31 MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SODIUM ALGINATE

Product Characteristics Color pink Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code SG;323 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50228-323-30 30 TABLET in 1 BOTTLE None 2 NDC:50228-323-01 100 TABLET in 1 BOTTLE None 3 NDC:50228-323-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207466 08/31/2017

Labeler — ScieGen Pharmaceuticals, Inc. (079391286)

Establishment
Name	Address	ID/FEI	Operations
ScieGen Pharmaceuticals, Inc.		079391286	analysis (50228-323), manufacture (50228-323)

Revised: 07/2021 ScieGen Pharmaceuticals, Inc.