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
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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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