Methocarbamol (Page 2 of 2)

Hemic and lymphatic system:

Leukopenia

Immune system:

Hypersensitivity reactions

Nervous system:

Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and special senses:

Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare at 1-888-869-8008 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Methocarbamol tablets, USP, 500 mg – Adults:

Initial dosage: 3 tablets q.i.d.

Maintenance dosage: 2 tablets q.i.d.

Methocarbamol tablets, USP: 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

750 mg tablets are modified capsule shape, white to off-white tablet, debossed S 226 on one side and plain on the reverse side.

They are supplied as follows:

Bottles of 40 NDC 63187-130-40

Bottles of 45 NDC 63187-130-45
Bottles of 60 NDC 63187-130-60
Bottles of 90 NDC 63187-130-90

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

Manufactured for:

Solco
Healthcare U.S.

Solco Healthcare U.S., LLC
Cranbury, NJ 08512

Manufactured by:
Emcure Pharmaceuticals USA Inc.
21-B, Cotters Lane
East Brunswick, NJ 08816

Prinston Laboratories
3241 Woodpark Blvd
Charlotte, NC 28206

M.F. # 0301-01
Rev. October 2012.

Rx only

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

750 mg Label

63187-130-40
(click image for full-size original)
METHOCARBAMOL
methocarbamol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-130(NDC:43547-226)
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
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape CAPSULE (capsule-shaped) Size 18mm
Flavor Imprint Code S226
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-130-40 40 TABLET in 1 BOTTLE None
2 NDC:63187-130-45 45 TABLET in 1 BOTTLE None
3 NDC:63187-130-60 60 TABLET in 1 BOTTLE None
4 NDC:63187-130-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086988 01/15/2013
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (63187-130), REPACK (63187-130)

Revised: 07/2020 Proficient Rx LP

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