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 & ADMINISTRATION

Methocarbamol Tablets, USP 500 mg – Adults:
Initial dosage: 3 tablets 4 times daily
Maintenance dosage: 2 tablets 4 times daily
Methocarbamol Tablets, USP 750 mg – Adults:
Initial dosage: 2 tablets 4 times daily
Maintenance dosage: 1 tablet every 4 hours or 2 tablets three times daily

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 light orange colored, roundshaped film coated tablets debossed with “G” above the score line on one side and “500″ on other side.

They are supplied as follows

Bottles of 24 tablets NDC 62207-754-41

Bottles of 100 tablets NDC 62207-754-43

Bottles of 500 tablets NDC 62207-754-47

Bottles of 1000 tablets NDC 62207-754-49

Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with “G” on one side and”750″ on other side.

Bottles of 24 tablets NDC 62207-770-41

Bottles of 100 tablets NDC 62207-770-43

Bottles of 500 tablets NDC 62207-770-47

Bottles of 1000 tablets NDC 62207-770-49


Store between 20ºC and 25ºC (68ºF and 77º F)

[see USP Controlled Room Temperature].

Dispense in tight container.

Manufactured for:

Granules USA, Inc.

Parsippany, NJ 07054

Toll-free: 1-877-770-3183


Manufactured by:

Granules India Limited

Hyderabad-500 081

Made in India

Issued: January 2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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METHOCARBAMOL methocarbamol tablets tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62207-754
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
STARCH, CORN
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE 2910 (6 MPA.S)
POLYSORBATE 80
PROPYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code G;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-754-41 24 TABLET, COATED in 1 BOTTLE None
2 NDC:62207-754-43 100 TABLET, COATED in 1 BOTTLE None
3 NDC:62207-754-47 500 TABLET, COATED in 1 BOTTLE None
4 NDC:62207-754-49 1000 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209312 05/15/2018
METHOCARBAMOL methocarbamol tablets tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62207-770
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
STARCH, CORN
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE 2910 (6 MPA.S)
POLYSORBATE 80
PROPYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-770-41 24 TABLET, COATED in 1 BOTTLE None
2 NDC:62207-770-43 100 TABLET, COATED in 1 BOTTLE None
3 NDC:62207-770-47 500 TABLET, COATED in 1 BOTTLE None
4 NDC:62207-770-49 1000 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209312 05/15/2018
Labeler — Granules India Ltd (915000087)
Establishment
Name Address ID/FEI Operations
Granules India Ltd 918609236 manufacture (62207-754), manufacture (62207-770), analysis (62207-754), analysis (62207-770), label (62207-754), label (62207-770), pack (62207-754), pack (62207-770)

Revised: 01/2020 Granules India Ltd

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