METHOCARBAMOL (Page 2 of 2)

OVERDOSAGE

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.


Treatment
Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

DOSAGE AND ADMINISTRATION

Methacarbamol 500 mg – Adults:
Initial dosage: 3 tablets q.i.d
Maintenance dosage: 2 tablets q.i.d


750 mg – Adults:
Initial dosage: 2 tablets q.i.d.
Maintenance dosage: 1 tablet q.4h, or 2 tablets t.i.d.


Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

HOW SUPPLIED

Methocarbamol tablets, USP 500 mg are white, round, scored, film-coated tablets, debossed “ASC” over the score on one side and “500” on the other side. They are supplied as follows:

100 counts: NDC 17511-505-01
500 counts: NDC 17511-505-05

Methocarbamol tablets, USP 750 mg are white, capsule-shaped, film-coated tablets, debossed “ASC” on one side and 750 on the other. They are supplied as follows:


100 counts: NDC 17511-506-01
500 counts: NDC 17511-506-05


Store between 20°C and 25°C (68°F and 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.


Manufactured For:
DBL Pharmaceuticals, Inc.
Jackson Heights, NY 11372

For more information, call ACI Healthcare USA, Inc. at 1-754-702-5116.


Manufactured By:
RA CHEM PHARMA LIMITED
Hyderabad 500076, TELANGANA, INDIA.


Distributed By:
ACI Healthcare USA, Inc.
10100 W. Sample Road, Suite 406
Coral Springs, FL 33065

Issued June 2018

Package Label for Methocarbamol 500mg & 750mg Tablet

container500mg100cc
(click image for full-size original)

container500mg500cc
(click image for full-size original)
container750mg100cc
(click image for full-size original)

container750mg500cc
(click image for full-size original)
METHOCARBAMOL methocarbamol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17511-505
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL (METHOCARBAMOL) METHOCARBAMOL 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code ASC;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17511-505-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:17511-505-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203550 02/08/2017
METHOCARBAMOL methocarbamol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17511-506
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL (METHOCARBAMOL) METHOCARBAMOL 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code ASC;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17511-506-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:17511-506-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203550 02/08/2017
Labeler — RA CHEM PHARMA LIMITED (650488088)
Registrant — DBL Pharmaceuticals, Inc. (080431908)
Establishment
Name Address ID/FEI Operations
RA CHEM PHARMA LIMITED 677637710 manufacture (17511-505), manufacture (17511-506)

Revised: 12/2018 RA CHEM PHARMA LIMITED

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