Metaxalone (Page 2 of 2)

ADVERSE REACTIONS

The most frequent reactions to metaxalone include:

CNS: drowsiness, dizziness, headache, and nervousness or “irritability”;

Digestive: nausea, vomiting, gastrointestinal upset.

Other adverse reactions are:

Immune System: hypersensitivity reaction, rash with or without pruritus;

Hematologic: leukopenia; hemolytic anemia;

Hepatobiliary: jaundice.

Though rare, anaphylactoid reactions have been reported with metaxalone.

To report SUSPECTED ADVERSE REACTIONS, contact Dr.Reddy’s Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch

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.

When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 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 55111-650-01: Bottles of 100 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.

You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call 1-888-375-3784.

Rx Only

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

Manufactured for:
Dr.Reddy’s Laboratories Inc.
Princeton, New Jersey 08540, USA Issued: 06/17

PRINCIPAL DISPLAY PANEL

metaxalone
(click image for full-size original)

METAXALONE metaxalone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1577(NDC:55111-650)
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
FERRIC OXIDE RED
COPOVIDONE
POVIDONE, UNSPECIFIED
ALGINIC ACID
STARCH, PREGELATINIZED CORN
SODIUM ALGINATE
MAGNESIUM STEARATE
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:67296-1577-5 15 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207466 01/01/2018
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1577)

Revised: 01/2022 RedPharm Drug, Inc.

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