Baclofen 5 mg/mL Suspension
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Baclofen is prescribed to reduce spasticity — the muscle stiffness, spasms, and rigidity that come with conditions like multiple sclerosis or spinal cord injury. Oral forms are als...
- What exactly is baclofen being used to treat — and will it help my pain too?
- Yes, and this is really important. Stopping baclofen suddenly — especially the pump form — can cause a dangerous withdrawal reaction: your spasticity can return much worse than bef...
- I heard you can't just stop taking baclofen — is that really true?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Baclofen — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.802 | $1,140.48 / 300 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.98 | $1,194.75 / 300 ml |
| Medicare drug plans payPart D · Q2 2026 | $4.91 | $1,474.32 / 300 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Baclofen 5 mg/mL 52536-0600-11 | Wilshire | 1 bottle | $3.768 | AB | Availability likely | save 1% |
| Baclofen 5 mg/mLthis 62559-0204-03 | ANI | 1 bottle | $3.802 | AB | Availability likely | — |
| Fleqsuvy 5 mg/mL 52652-6001-01 | Azurity | 1 bottle | $5.982 | AB | Availability likely | +57% |
| Baclofen 5 mg/mL 71225-0140-01 | Slayback | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62559-0204-03 You're viewing this | 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE | $3.80 / mL | $1,140.49 | 2024-03-19 | Active |
| 62559-0204-12 | 1 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLE | $3.77 / mL | $452.17 | 2024-03-18 | Active |
This pack accounts for about 13% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 62559-0204-03?
What NDC number is used to bill for this package of Baclofen 5 mg/mL Suspension?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Baclofen oral suspension is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. • Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
( 1 ) • Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Baclofen oral suspension is a concentrated formulation. Verify the dose of the product prior to dispensing. ( 2.1 ) • Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) • The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) • When discontinuing, reduce the dosage slowly. ( 2.3 )
2.1Important Information Baclofen oral suspension is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering.
2.2Recommended Dosage Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) three times a day for three days 2 mL (10 mg) three times a day for three days 3 mL (15 mg) three times a day for three days 4 mL (20 mg) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times a day].
2.3Administration Instructions Shake well baclofen oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.
2.4Discontinuation of Baclofen Oral Suspension When discontinuing baclofen oral suspension, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 25 mg per 5 mL (5 mg/mL) baclofen as a concentrated white to off white, grape-flavored suspension. Oral Suspension: 25 mg per 5 mL (5 mg/mL) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. • Hypersensitivity to baclofen ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral suspension is discontinued. ( 5.1 ) • Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral suspension before delivery. ( 5.2 ) • Baclofen oral suspension can cause drowsiness and sedation.
Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants. ( 5.3 ) • Baclofen oral suspension can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy.
Use with caution in patients with these conditions. ( 5.5 , 5.6 , 5.7 )
5.1Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Suspension Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen oral suspension is discontinued, unless the clinical situation justifies a rapid withdrawal.
5.2Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. 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 baclofen oral suspension is continued during pregnancy, gradually reduce the dosage and discontinue baclofen oral suspension before delivery.
If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.
5.3Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen oral suspension [see Adverse Reactions ( 6.1 )] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen oral suspension or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants.
5.4Poor Tolerability in Stroke Patients Baclofen oral suspension should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
5.5Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen oral suspension should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen oral suspension, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.
5.6Exacerbation of Autonomic Dysreflexia Baclofen oral suspension should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen oral suspension may cause an autonomic dysreflexic episode.
5.7Exacerbation of Epilepsy Baclofen oral suspension should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.
5.8Posture and Balance Effects Baclofen oral suspension should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomo…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Suspension [see Warnings and Precautions ( 5.1 )] • Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] • Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] • Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] • Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] • Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] • Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] • Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] • Ovarian Cysts [see Warnings and Precautions ( 5.9 )] • The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group.
Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1. Table 1.
Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1CNS Depressants and Alcohol Baclofen oral suspension can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) • Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function. ( 8.6 )
8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen oral suspension in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations) . Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen oral suspension may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] .
Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.
8.2Lactation Risk Summary At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production. Withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen oral suspension is stopped, or when breastfeeding is stopped [see Warnings and Precautions ( 5.2 )] .
There are no adequate data on other effects of baclofen on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for baclofen oral suspension and any potential adverse effects on the breastfed infant from baclofen oral suspension or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.
8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations ( 8.6 )].
8.6Renal Impairment Because baclofen is primarily excreted unchanged through the kidneys, baclofen oral suspension should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen oral suspension in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations) . Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen oral suspension may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] .
Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations ( 8.6 )].
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Symptoms of Baclofen Overdose With overdose of baclofen, patients may present in coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.
10.2Treatment for Overdose The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.
12.2Pharmacodynamics Baclofen has been shown to have general CNS depressant properties, as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 ), and Overdosage ( 10.1 )].
12.3Pharmacokinetics A pharmacokinetic study in heathy adult male and female subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral suspension and oral tablets. Absorption The peak plasma concentrations of baclofen were achieved in about 1 hour from administration of baclofen oral suspension in the fasted state, and the apparent elimination half-life is about 5.6 hours. Effect of Food Administration of baclofen oral suspension with a high-fat meal resulted in 9% decrease in AUC and 33% decrease in C max compared to the fasted state.
Elimination Baclofen is excreted primarily by the kidney in unchanged form, and there is relatively large intersubject variation in absorption and/or elimination.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Baclofen Oral Suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a white to off white viscous suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and tamper evident band. It is available as: 120 mL bottle NDC 62559-204-12 250 mL bottle NDC 62559-204-25 300 mL bottle NDC 62559-204-03
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.
📋 Description ▾
11 DESCRIPTION Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 C1NO 2 . Molecular Weight is 213.66 g/mol.
Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral suspension inactive ingredients are artificial grape flavor, hydrochloric acid, hypromellose, methyl paraben, propyl paraben, purified water, simethicone emulsion, sodium hydroxide, sucralose, and xanthan gum.
Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients that baclofen oral suspension is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy.
Instruct patients to shake before using [see Dosage and Administration ( 2.1 , 2.3 )] . Risks Related to Sudden Withdrawal of Baclofen Oral Suspension Advise patients and caregivers not to discontinue use of baclofen oral suspension without consulting with their healthcare provider because sudden withdrawal of baclofen oral suspension can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [see Warnings and Precautions ( 5.1 )].
Inform patients that early symptoms of baclofen oral suspension withdrawal may include increased spasticity, itching, and tingling of extremities. Neonatal Withdrawal Symptoms Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.2 )]. Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Advise patients that baclofen oral suspension may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting baclofen oral suspension or increasing the dose until they know how the drug affects them [see Warnings and Precautions ( 5.3 )].
Inform patients and their caregivers that the drowsiness associated with baclofen oral suspension use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their healthcare provider about all prescription and nonprescription drugs they may use. Storage Instruct patients to store baclofen oral suspension at room temperature and to discard unused portion 2 months after first opening [see How Supplied/Storage and Handling ( 16.2 )].
Manufactured by: Bora Pharmaceutical Services Inc. Mississauga, ON L5N 6L4 Canada Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Revised: 06/2025 ani_logo