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 are available as 800 mg pink, capsule shaped, scored tablets, debossed “LCI” on one side and “14” bisect “35” on the other side. Available in

NDC: 70518-0771-00

NDC: 70518-0771-01

NDC: 70518-0771-02

NDC: 70518-0771-03

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 60 in 1 BOTTLE PLASTIC

PACKAGING: 25 in 1 BOTTLE PLASTIC

Store at 20º C to 25º C (68º to 77ºF) [See USP Controlled Room Temperature].

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Metaxalone

GENERIC: Metaxalone

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0771-0

NDC: 70518-0771-1

NDC: 70518-0771-2

NDC: 70518-0771-3

COLOR: pink

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: LCI;1435

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 60 in 1 BOTTLE PLASTIC

PACKAGING: 25 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • METAXALONE 800mg in 1

INACTIVE INGREDIENT(S):

  • CARBOXYMETHYLCELLULOSE SODIUM
  • ALGINIC ACID
  • SILICON DIOXIDE
  • FD&C RED NO. 40
  • ALUMINUM OXIDE
  • HYDROGENATED CASTOR OIL
  • STEARIC ACID
  • SODIUM LAURYL SULFATE
  • MAGNESIUM STEARATE
MM1
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
METAXALONE metaxalone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0771(NDC:0527-1435)
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
CARBOXYMETHYLCELLULOSE SODIUM
ALGINIC ACID
SILICON DIOXIDE
FD&C RED NO. 40
ALUMINUM OXIDE
HYDROGENATED CASTOR OIL
STEARIC ACID
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
Product Characteristics
Color pink Score 2 pieces
Shape OVAL (capsule-shaped) Size 19mm
Flavor Imprint Code LCI;1435
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0771-0 90 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:70518-0771-1 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:70518-0771-2 60 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:70518-0771-3 25 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204770 10/09/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2024 REMEDYREPACK INC.

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