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NDC 51552-0613-07

Baclofen 1 g/g POWDER

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NDC
51552-0613-07
Generic Name
Baclofen
Brand Name
Strength
1 g/g
Dosage Form
POWDER
Route
Package Size
Labeler
Fagron Inc

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are n…

Important Warnings

WARNINGS a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen i…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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