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.

metaxalone-800mg-30tab
(click image for full-size original)

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.

metaxalone-800mg-100tab
(click image for full-size original)

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-800mg-500tab
(click image for full-size original)
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.

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